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DRUG:

Simulect (basiliximab)

i
Other names: CHI 621, Chimeric RFT5, chRFT5, SDZ CHI 621, CHI-621, CHI621
Associations
Company:
Novartis
Drug class:
CD25 inhibitor
Associations
14d
Phase classification
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Simulect (basiliximab)
4ms
ONSET: 1 vs 7 RATG Infusions in Renal Transplantation (clinicaltrials.gov)
P=N/A, N=75, Not yet recruiting, Mario Negri Institute for Pharmacological Research | Trial completion date: Jun 2025 --> Sep 2025 | Initiation date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2025 --> Sep 2025
Trial completion date • Trial initiation date • Trial primary completion date
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Simulect (basiliximab)
6ms
Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome (clinicaltrials.gov)
P4, N=169, Completed, Chong Kun Dang Pharmaceutical | Active, not recruiting --> Completed
Trial completion
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Simulect (basiliximab)
7ms
ONSET: 1 vs 7 RATG Infusions in Renal Transplantation (clinicaltrials.gov)
P=N/A, N=75, Not yet recruiting, Mario Negri Institute for Pharmacological Research
New trial
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Simulect (basiliximab)
8ms
Trial completion date
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CD34 (CD34 molecule)
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cytarabine • etoposide IV • carmustine • melphalan • Simulect (basiliximab)
8ms
Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=20, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date
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ALK (Anaplastic lymphoma kinase) • CD34 (CD34 molecule)
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cytarabine • etoposide IV • etoposide oral • carmustine • melphalan • Simulect (basiliximab)
9ms
Mesenchymal stromal cells plus basiliximab improve the response of steroid-refractory acute graft-versus-host disease as a second-line therapy: a multicentre, randomized, controlled trial. (PubMed, BMC Med)
For SR-aGVHD after allo-HSCT, especially HID HSCT, the combination of MSCs and basiliximab as the second-line therapy led to significantly better 4-week CR rates than basiliximab alone. The addition of MSCs not only did not increase toxicity but also provided a survival benefit.
Journal • Stroma
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PD-L1 (Programmed death ligand 1) • TGFB1 (Transforming Growth Factor Beta 1)
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Simulect (basiliximab)
10ms
90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
P1, N=12, Recruiting, City of Hope Medical Center | Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Feb 2024 --> Dec 2024
Trial completion date • Trial primary completion date
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • IL2RA (Interleukin 2 receptor, alpha) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
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MLL rearrangement • IL2RA expression • Chr t(9;11)
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melphalan • fludarabine IV • Kepivance (palifermin) • Simulect (basiliximab)
10ms
Stem Cell Transplantation for Patients With Multiple Myeloma (clinicaltrials.gov)
P1, N=15, Active, not recruiting, University of Chicago | Trial completion date: Sep 2023 --> Sep 2025 | Trial primary completion date: Sep 2023 --> Sep 2025
Trial completion date • Trial primary completion date
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IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • FOXP3 (Forkhead Box P3) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
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melphalan • Simulect (basiliximab) • plerixafor
10ms
A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients (clinicaltrials.gov)
P2, N=149, Completed, Astellas Pharma Global Development, Inc. | Phase classification: P2a --> P2
Phase classification
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prednisone • Simulect (basiliximab)
10ms
Non-IL-2-blocking anti-CD25 antibody inhibits tumor growth by depleting Tregs and has synergistic effects with anti-CTLA-4 therapy. (PubMed, Int J Cancer)
However, marketed anti-CD25 antibodies (Basiliximab and Daclizumab) were originally developed as immunosuppressive drugs to prevent graft rejection, because these antibodies can block IL-2 binding to CD25 on Teffs, which in turn destroys the function of Teffs. Moreover, our findings reveal that the Fab form of h7B7-15S has the ability to deplete Tregs, independent of the Fc region. Taken together, our studies expand the application of anti-CD25 in tumor immunotherapy and provide insight into the underlying mechanism.
Journal
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IL2 (Interleukin 2)
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Simulect (basiliximab) • Zinbryta (daclizumab)
11ms
Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant (clinicaltrials.gov)
P2, N=2, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed | N=20 --> 2
Trial completion • Enrollment change
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Simulect (basiliximab)
12ms
SIMPLE: Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR (clinicaltrials.gov)
P4, N=80, Recruiting, University of Southern California | Trial completion date: Feb 2023 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2025
Trial completion date • Trial primary completion date
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prednisone • Simulect (basiliximab)
12ms
Targeting of CD25+ Activated T Cells in Gvhd-Associated Marrow Suppression and Cytopenias (ASH 2023)
We describe 3 cases of GVHD-associated cytopenias marked by HSPC depletion and presence of CD25 (IL-2R alpha subunit)-positive activated T cells in the marrow that responded to combinations of immunosuppression containing basiliximab (basil) anti-CD25 monoclonal antibody blockade...P1 received prednisone, CNI, and rituximab for a presumed anti-HSPC autoantibody...P3 has received prednisone, CNI, and sirolimus indefinitely for prevention of liver rejection and/or hepatocellular carcinoma relapse... We describe combined HSPC and T cell analyses in 3 patients (P) with severe GVHD-associated cytopenias. P1 was at 5 years post-HCT for acute lymphoblastic leukemia, P2 at 2 years post-HCT for severe aplastic anemia (SAA), and P3 at 1. 5 months post-liver transplant for alcohol use disorder-associated cirrhosis and hepatocellular carcinoma ( Table 1).
IO biomarker
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IL2RA (Interleukin 2 receptor, alpha) • CD34 (CD34 molecule) • CD69 (CD69 Molecule)
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Rituxan (rituximab) • prednisone • sirolimus • Simulect (basiliximab)
1year
Chimeric Antigen-Receptor (CAR)-Engineered Natural Killer (NK) Cells Targeting Chronic Myeloid Leukemia (CML) Blast Crisis (ASH 2023)
Here we show the experimental development of a third-generation CAR-NK therapy strategy against the CD25 based on the scFV of the clinically approved monoclonal humanized antibody, Basiliximab... We show here for the first time the potential use of an NK cell-mediated CAR therapy strategy targeting CD25 which has been shown to be upregulated in CML blast crisis. The experimental data show a significantly increased and selective in vitro and in vivo cytotoxicity of CD25 CAR-NK92 cells against CD25-expressing leukemia cells as compared to WT-NK92 cells. These results suggest that targeting CD25 by a CD25 CAR based on Basilixiamb's scFV might be an interesting tool in BC-CML and in all acute leukemias overexpressing CD25.
IO biomarker
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IFNG (Interferon, gamma) • IL2RA (Interleukin 2 receptor, alpha) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • LAMP1 (Lysosomal Associated Membrane Protein 1) • GZMB (Granzyme B) • ANXA5 (Annexin A5)
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IL2RA expression • CD2 overexpression • IL2R overexpression
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Simulect (basiliximab)
1year
Long-Term Outcome of a Unique Haploidentical High-Dose Peripheral Stem Cell Transplantation Protocol for Hematologic Malignancies: A Prospective Single-Center Study (ASH 2023)
Background Although many reports have established the efficacy of post-transplantation cyclophosphamide (PTCy) or ATG for GVHD prophylaxis to in vitro non-T cell-depleted (non-TCD) haplo-HSCT and achieved a good clinical effect, the overall results of NRM, RI, DFS, and OS still need to be improved, especially for patients with high-risk or R/R hematologic malignancies...Our haplo-HDPSCT protocol was designed adopting high-dose in vitro non-TCD PBSCs as graft, Ara-C+Bu/Cy+rATG as the conditioning regimen, and Basiliximab plus short-term low-dose GCs added to standard GVHD prophylaxis...Only two patients in the haplo-HDPSCT group developed PTLD. Conclusions This study demonstrates that aGVHD is not high in our haplo-HDPSCT protocol and the long-term follow-up shows that this protocol may bring benefits including high engraftment rate, less relapse and viral infection, which implies that higher doses of in vitro non-TCD PBSCs as a graft source for haplo-HSCT protocol is feasible if appropriate GVHD prophylaxis is adopted.
Clinical
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CD34 (CD34 molecule)
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cytarabine • cyclophosphamide • Simulect (basiliximab)
1year
New trial
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Simulect (basiliximab)
1year
Early steroids after paediatric liver transplantation protect against T-cell mediated rejection -results from the ChilSFree study. (PubMed, Liver Transpl)
Adjunctive steroid therapy after pLT leads to earlier suppression of the post-pLT pro-inflammatory response and significantly reduced rejection rates during the first year after pLT (15.9%). 65% of patients initially treated without steroids remain steroid free over the first 12 months without rejection.
Journal
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL2 (Interleukin 2) • IL7 (Interleukin 7)
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cyclosporine • Simulect (basiliximab)
over1year
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma (clinicaltrials.gov)
P2, N=33, Recruiting, City of Hope Medical Center | Trial completion date: Nov 2026 --> Oct 2027 | Trial primary completion date: Nov 2024 --> Oct 2027
Trial completion date • Trial primary completion date
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CD34 (CD34 molecule)
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cytarabine • etoposide IV • carmustine • melphalan • Simulect (basiliximab) • Starasid (cytarabine ocfosfate)
over1year
BASILIXIMAB MAY BE THE POTENTIAL SOLUTION FOR SEVERE LIVER CHRONIC GRAFT-VERSUS-HOST DISEASE: A PROSPECTIVE PILOT STUDY (EHA 2023)
Basiliximab treatment administered on the basis of corticosteroid and CNI helped to effectively control the severe liver cGVHD, and basiliximab may provide a potential solution for these patients. Allogeneic hematopoietic stem cell transplant, Liver, Chronic graft-versus-host, Bilirubin
Clinical
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IL2 (Interleukin 2)
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Simulect (basiliximab)
over1year
Use of Basiliximab as Adjunct Maintenance Immunosuppressant in Pancreas Transplant Recipients [Board No. C301] (ATC 2023)
Recognizing that basiliximab was initiated for an “at-risk” patient population, this study demonstrates that monthly basiliximab infusions can be considered as an alternative maintenance immunosuppressive agent in pancreas transplant recipients who have failed other conventional agents.
Clinical
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sirolimus • Simulect (basiliximab)
over1year
Graft versus Host Disease (GVHD) in Adult Liver Transplant Recipients: A Single Center Experience [Board No. C208] (ATC 2023)
In addition to systemic steroids, basiliximab was the primary induction immunosuppression in 60% recipients with GVHD...Management strategies included combination of holding immunosuppression in 80% initially, use of systemic steroids in 50%, etanercept in 30%, ATG in 20%, and bone marrow transplant (BMT) in one... GVHD remains uncommon but fatal in LT recipients. In our experience, most cases present within the first 2-months after LT, and GVHD should be suspected when LT recipients develop skin rash, diarrhea, and/or pancytopenia. Skin only involvement portends a good prognosis, while multi-system involvement, and a wide Recipient-Donor age mismatch are poor prognosticators.
Clinical
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Simulect (basiliximab)
over1year
Stem Cell Transplantation for Patients With Multiple Myeloma (clinicaltrials.gov)
P1, N=15, Active, not recruiting, University of Chicago | Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Dec 2018 --> Sep 2023
Trial completion date • Trial primary completion date
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IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • IL7R (Interleukin 7 Receptor) • FOXP3 (Forkhead Box P3) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
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melphalan • Simulect (basiliximab) • plerixafor
over1year
Trial completion date
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CD34 (CD34 molecule)
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cytarabine • etoposide IV • carmustine • melphalan • Simulect (basiliximab)
over1year
Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=20, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2022 --> Dec 2023
Trial completion date
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ALK (Anaplastic lymphoma kinase) • CD34 (CD34 molecule)
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cytarabine • etoposide IV • etoposide oral • carmustine • melphalan • Simulect (basiliximab)
over1year
EBV-Negative Monomorphic Post-Transplant Lymphoproliferative Disorder associated with Hemophagocytic Lymphohistiocytosis in an Adult Kidney Transplant Recipient (NKF-SCM 2023)
He received basiliximab for induction IS and prednisone/tacrolimus/mycophenolate mofetil for maintenance IS...His fever, cytopenias and inflammatory markers improved with dexamethasone with no evidence of relapse. One year after his HLH diagnosis, he was evaluated for PTH-independent hypercalcemia (1,25OH-VitD 147pg/ml[20-79]): a whole-body PET/CT now showed diffuse hypermetabolic activity and a retroperitoneal mass biopsy revealed monomorphic DLBCL-PTLD.Results There have been reported cases of adult kidney transplant recipients developing HLH either concurrently with PTLD[1] or a few weeks following the PTLD diagnosis[2]. However, the diagnosis of HLH in our case preceded the identification of PTLD.Conclusion Therefore, our case illustrates that active surveillance for an underlying PTLD should be considered in transplant recipients when there is no initial evidence of malignancy at the time of HLH diagnosis, especially since hematologic malignancies are the most common trigger for HLH in adults.
Clinical • Post-transplantation
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IL2 (Interleukin 2)
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prednisone • dexamethasone • Simulect (basiliximab)
almost2years
90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
P1, N=12, Recruiting, City of Hope Medical Center | Trial completion date: Jul 2024 --> Feb 2024 | Trial primary completion date: Jul 2024 --> Feb 2024
Trial completion date • Trial primary completion date
|
FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • IL2RA (Interleukin 2 receptor, alpha)
|
MLL rearrangement • IL2RA expression • Chr t(9;11)
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melphalan • fludarabine IV • Kepivance (palifermin) • Simulect (basiliximab)
2years
Successful Kidney and Hematopoietic Stem Cell Transplantation for Malignant Lymphoma from Different Donors: A Case Report and Literature Review. (PubMed, Transplant Proc)
Immunosuppressive therapy with tacrolimus, mycophenolate mofetil, methylprednisolone, and basiliximab was administered. The patient had urinary tract infections at 7 days, 9 weeks, and 4 months after kidney transplantation, and cytomegalovirus antigenemia at 9 weeks after kidney transplantation, which improved with antibiotic and valganciclovir, respectively...In this case, we believe that it was important to optimize the immunosuppressive therapy. In addition, from a review of previous cases, it seemed important that there was no GVHD requiring maintenance therapy in order to prevent excessive immunosuppression.
Review • Journal
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HLA-B (Major Histocompatibility Complex, Class I, B)
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Simulect (basiliximab) • Valcyte (valganciclovir)
2years
Epstein Barr Virus (EBV)- associated to Smooth Muscle Tumor (SMT) in a renal transplant recipient: Case Report. (IPNA 2022)
Induction with Basiliximab and maintenance: prednisone, MMF and tacrolimus. The majority of them are associated with solid organ transplantation and HIV infection. Current treatment include surgical resection, minimizing immunosuppression and sirolimus but further research is needed to establish the response to new treatments
Clinical
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WT1 (WT1 Transcription Factor)
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WT1 mutation
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prednisone • sirolimus • Simulect (basiliximab)
2years
A RARE CASE OF ANTI-MDA5 ANTIBODY-ASSOCIATED RAPIDLY PROGRESSIVE INTERSTITIAL LUNG DISEASE WITHOUT CUTANEOUS MANIFESTATIONS (CHEST 2022)
Two recent studies from Japan showed that patients initially treated with a combination of high-dose corticosteroids, tacrolimus, and cyclophosphamide had higher 6-month survival than patients treated with high-dose corticosteroids followed by the addition of immunosuppressant agents. Other treatment options for patients with refractory illness include mycophenolate mofetil, rituximab, basiliximab, or tofacitinib... Anti-MDA5 antibody screening should be considered in all patients with RP-ILD even in the absence of cutaneous manifestations associated with CADM. More research is needed to help guide management and discover effective treatments options.
Clinical
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IFIH1 (Interferon Induced With Helicase C Domain 1)
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Rituxan (rituximab) • cyclophosphamide • tofacitinib • Simulect (basiliximab)
over2years
I Radiolabeled Basiliximab for CD25-Targeted Immuno-PET Imaging of Activated T Cells. (PubMed, Mol Pharm)
More importantly, PHA-activated hPBMC had much higher uptake of I-Basiliximab, indicating the potential utility of I-Basiliximab to discriminate activated hPBMC from its non-activated status. In summary, I-Basiliximab was fabricated for the first time, which can be applied in CD25-targeted immuno-PET imaging of activated T cells in vivo.
Journal • IO biomarker
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IL2RA (Interleukin 2 receptor, alpha)
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IL2RA expression
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Simulect (basiliximab)
over2years
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma (clinicaltrials.gov)
P2, N=33, Recruiting, City of Hope Medical Center | Trial completion date: Apr 2023 --> Nov 2026 | Trial primary completion date: Apr 2023 --> Nov 2024
Trial completion date • Trial primary completion date
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CD34 (CD34 molecule)
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cytarabine • etoposide IV • carmustine • melphalan • Simulect (basiliximab)
over2years
SEVERE IMMUNE CHECKPOINT INHIBITOR ASSOCIATED HEPATITIS SUCCESSFULLY TREATED WITH BASILIXIMAB (ASPHO 2022)
First line therapy remains discontinuation of the ICI and initiation of steroids, with some literature supporting T-cell-specific immunomodulators such as mycophenolate, tacrolimus, or azathioprine as second line agents...Design/ Case ReportA 22-year-old female with recurrent metastatic osteosarcoma of her right proximal tibia began treatment with the anti-PD-1 monoclonal antibody nivolumab for refractory disease...Given continued elevation in her LFTs, further treatments included everolimus, rabbit ATG, and tacrolimus, none of which were successful in persistently decreasing her LFTs, which peaked at greater than 20 times normal, indicating a Grade 4 adverse event... Basiliximab may be an effective therapy for steroid-resistant severe ICI associated hepatitis.
Checkpoint inhibition
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CD4 (CD4 Molecule)
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Opdivo (nivolumab) • everolimus • Simulect (basiliximab)
over2years
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma (clinicaltrials.gov)
P2, N=33, Recruiting, City of Hope Medical Center | Trial completion date: Nov 2023 --> Apr 2023 | Trial primary completion date: Nov 2023 --> Apr 2023
Trial completion date • Trial primary completion date
|
CD34 (CD34 molecule)
|
cytarabine • etoposide IV • carmustine • melphalan • Simulect (basiliximab)
over2years
Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=25, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2018 --> Jul 2021
Trial completion date • Trial primary completion date
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CD34 (CD34 molecule)
|
cytarabine • etoposide IV • carmustine • melphalan • Simulect (basiliximab)
over2years
Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=20, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
Trial completion date • Trial primary completion date
|
ALK (Anaplastic lymphoma kinase) • CD34 (CD34 molecule)
|
cytarabine • etoposide IV • etoposide oral • carmustine • melphalan • Simulect (basiliximab)
over2years
90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
P1, N=12, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Jun 2023 --> Jul 2024 | Initiation date: Dec 2021 --> Jul 2024 | Trial primary completion date: Jun 2023 --> Jul 2024
Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • IL2RA (Interleukin 2 receptor, alpha)
|
MLL rearrangement • IL2RA expression
|
melphalan • fludarabine IV • Kepivance (palifermin) • Simulect (basiliximab)
almost3years
New P1 trial
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • IL2RA (Interleukin 2 receptor, alpha)
|
MLL rearrangement • IL2RA expression
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melphalan • fludarabine IV • Kepivance (palifermin) • Simulect (basiliximab)
3years
SELECTIVE TREG DEPLETION IN SOLID TUMORS WITH ALD2510, A NOVEL HUMANIZED CD25-SPECIFIC, IL-2 SPARING MONOCLONAL ANTIBODY. (SITC 2021)
Importantly, Basiliximab, a CD25-specific IL-2 blocking antibody, although efficient at depleting Treg cells, did not impact tumor growth, thus demonstrating that the IL-2 sparing feature of ALD2510 is critical to elicit anti-tumour response in vivo. Conclusions This preclinical data package supports CD25 as a potent and selective Treg marker allowing Tregs depletion while sparing conventional T cells. In this context, ALD2510, a novel humanized CD25-specific and IL-2 sparing antibody presents all the required attributes for selective and efficient TIL-Tregs depletion, making it a promising drug candidate to treat a broad range of solid tumor patients.
PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CD34 (CD34 molecule) • IL2 (Interleukin 2)
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CD8 expression • IL2RA expression
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ALD2510 • Simulect (basiliximab)