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BIOMARKER:

CD19 positive

i
Other names: CD19, CD19 Molecule, B-Lymphocyte Surface Antigen B4, T-Cell Surface Antigen Leu-12, Differentiation Antigen CD19, B-Lymphocyte Antigen CD19, CD19 Antigen, CVID3, B4
Entrez ID:
Related biomarkers:
5d
Enrollment closed
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CD19 positive
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lenalidomide • Monjuvi (tafasitamab-cxix)
6d
Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
P1, N=36, Recruiting, Mehrdad Abedi, MD | Trial completion date: Feb 2025 --> Dec 2025 | Trial primary completion date: Aug 2024 --> May 2025
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
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CD19 positive
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Rituxan (rituximab) • cyclophosphamide • Truxima (rituximab-abbs) • fludarabine IV
9d
Enrollment change
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CD19 positive
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AZD0486
9d
Targeting CD19-positive lymphomas with the antibody-drug conjugate loncastuximab tesirine: preclinical evidence as single agent and in combination therapy. (PubMed, Haematologica)
Loncastuximab tesirine was more potent than other anti-CD19 ADCs (coltuximab ravtansine, huB4-DGN462), albeit the pattern of activity across cell lines was correlated. Loncastuximab tesirine activity was also largely correlated with cell line sensitivity to R-CHOP...Our data support the further development of loncastuximab tesirine as a single agent and in combination for patients affected by mature B-cell neoplasms. The results also highlight the importance of CD19 expression and the existence of lymphoma populations characterized by resistance to multiple therapies.
Preclinical • Journal • Combination therapy • IO biomarker
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BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule)
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CD19 positive • CD19 expression
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Rituxan (rituximab) • Zynlonta (loncastuximab tesirine-lpyl) • coltuximab ravtansine (SAR3419)
15d
Trial completion date
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CD19 (CD19 Molecule)
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CD19 positive • CD19 expression
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UCD19 CAR T Cells
17d
TRANSCEND-CLL-004: Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov)
P1/2, N=209, Recruiting, Juno Therapeutics, a Subsidiary of Celgene | Active, not recruiting --> Recruiting | Trial completion date: Jul 2026 --> Nov 2027 | Trial primary completion date: Jul 2026 --> Nov 2027
Enrollment open • Trial completion date • Trial primary completion date
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PLCG2 (Phospholipase C Gamma 2) • CD5 (CD5 Molecule)
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CD19 positive • PLCG2 mutation
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Venclexta (venetoclax) • Imbruvica (ibrutinib) • Breyanzi (lisocabtagene maraleucel)
17d
Pembrolizumab and Blinatumomab in Treating Participants With Recurrent or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1/2, N=36, Recruiting, City of Hope Medical Center | Trial completion date: Apr 2024 --> Oct 2024 | Trial primary completion date: Apr 2024 --> Oct 2024
Trial completion date • Trial primary completion date • Combination therapy
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PD-L1 (Programmed death ligand 1)
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CD19 positive
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Keytruda (pembrolizumab) • Blincyto (blinatumomab)
1m
New P2 trial
|
CD19 positive
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cyclophosphamide • fludarabine IV • humanized CD19 CAR-T cells
1m
huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia (clinicaltrials.gov)
P1, N=55, Terminated, Fred Hutchinson Cancer Center | Active, not recruiting --> Terminated; Terminated due to slow enrollment and end of funding
Trial termination • CAR T-Cell Therapy
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BCL2 (B-cell CLL/lymphoma 2) • CD19 (CD19 Molecule) • BCL6 (B-cell CLL/lymphoma 6) • IL6 (Interleukin 6) • CD4 (CD4 Molecule) • SELL (Selectin L)
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CD19 positive • CD8 expression • CD19 expression • BCL6 rearrangement • BCL2 rearrangement • CD20 negative • CD4 expression
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cyclophosphamide • fludarabine IV • JCAR014
1m
EP300-ZNF384 transactivates IL3RA to promote the progression of B-cell acute lymphoblastic leukemia. (PubMed, Cell Commun Signal)
Doxorubicin displayed a selective killing of EP300-ZNF384-positive B-ALL cells in vitro and in vivo. Collectively, we identify IL3RA as a direct downstream target of EP300-ZNF384, suggesting CD123 is a potent biomarker for EP300-ZNF384-driven B-ALL. Targeting CD123 may be a novel therapeutic approach to EP300-ZNF384-positive patients, alternative or, more likely, complementary to standard chemotherapy regimen in clinical setting.
Journal
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CD123 (Interleukin 3 Receptor Subunit Alpha) • EP300 (E1A binding protein p300) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • STAT5A (Signal Transducer And Activator Of Transcription 5A) • ZNF384 (Zinc Finger Protein 384)
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CD19 positive • CD123 expression • IL3RA expression
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doxorubicin hydrochloride
1m
A high-content screen of FDA approved drugs to enhance CAR T cell function: ingenol-3-angelate improves B7-H3-CAR T cell activity by upregulating B7-H3 on the target cell surface via PKCα activation. (PubMed, J Exp Clin Cancer Res)
This study demonstrates a novel high-content and high-throughput screen can identify drugs to enhance CAR T cell activity. This and other high-content technologies will pave the way to develop clinical trials implementing rational drug plus CAR T cell combinatorial therapies. Importantly, the technique could also be repurposed for an array of basic and translational research applications where drugs are needed to modulate cell surface protein expression.
FDA event • Journal • CAR T-Cell Therapy
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CD276 (CD276 Molecule) • PRKCA (Protein Kinase C Alpha)
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CD19 positive • CD276 expression
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B7-H3 CAR-T
2ms
CD19 CAR-expressing iPSC-derived NK cells effectively enhance migration and cytotoxicity into glioblastoma by targeting to the pericytes in tumor microenvironment. (PubMed, Biomed Pharmacother)
Compared to GBM spheroids, the presence of pericytes significantly enhanced CD19 CAR-iNK cell migration towards GBM and reduced proliferation. These results underline the efficacy of CD19 CAR-iNK cells in targeting pericytes within the GBM TME, suggesting their potential therapeutic value for GBM treatment.
Journal
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CD19 (CD19 Molecule)
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CD19 positive • CD19 expression
2ms
Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL (clinicaltrials.gov)
P2, N=2, Active, not recruiting, University of Maryland, Baltimore | Trial completion date: Nov 2024 --> Aug 2027
Trial completion date • Minimal residual disease
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CD81 (CD81 Molecule)
|
CD19 positive
|
Blincyto (blinatumomab)
2ms
Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen Receptor (CAR) Gene-transduced T Lymphocytes) for Relapsed or Refractory CD19+ B-cell Lymphoma, CLL/SLL (clinicaltrials.gov)
P1, N=19, Recruiting, University Health Network, Toronto | Trial completion date: Nov 2025 --> May 2026 | Trial primary completion date: Nov 2024 --> Mar 2025
Trial completion date • Trial primary completion date
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CD19 positive
|
cyclophosphamide • fludarabine IV
2ms
CAR19T2: CD19 CAR T-cell Target Relapsed/Refractory Acute B Cell Leukemia/Lymphoma (clinicaltrials.gov)
P1/2, N=0, Withdrawn, Zhujiang Hospital | N=70 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal • CAR T-Cell Therapy
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CD19 positive
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cyclophosphamide • CAR19T2 T cells
2ms
Allogenic CD19-targeting CAR-γδT Cell Therapy in r/r NHL (clinicaltrials.gov)
P1/2, N=30, Recruiting, Chinese PLA General Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • Chr t(11;14) • CCND1 overexpression • BCL6 rearrangement • Chr t(11;14)(q13;q32) • BCL2 rearrangement • CD20 negative
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cyclophosphamide • fludarabine IV
2ms
Clinical Trial of HY004 Cell Injection in the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P1/2, N=80, Not yet recruiting, Juventas Cell Therapy Ltd. | Initiation date: Oct 2023 --> Aug 2024
Trial initiation date
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BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • IL6 (Interleukin 6) • CD22 (CD22 Molecule)
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CD19 positive • BCL6 rearrangement • BCL2 rearrangement
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cyclophosphamide • HY004
2ms
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P2, N=60, Recruiting, Juventas Cell Therapy Ltd. | Trial primary completion date: Dec 2023 --> Jun 2024
Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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CD19 positive • BCL6 rearrangement • BCL2 rearrangement • CD20 negative
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cyclophosphamide • Yuanruida (inaticabtagene autoleucel)
2ms
GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL (clinicaltrials.gov)
P1/2, N=36, Recruiting, AO GENERIUM | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Feb 2025
Trial completion date • Trial primary completion date
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CD19 positive
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GNR-084
3ms
Enrollment closed
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CD19 (CD19 Molecule) • CD22 (CD22 Molecule)
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CD19 positive • CD19 expression • CD22 expression
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cyclophosphamide • fludarabine IV • NKTR-255
3ms
Direct and Indirect Chimeric Antigen Receptor T-Cell Imaging with PET/MRI in a Tumor Xenograft Model. (PubMed, Radiology)
© RSNA, 2024 Supplemental material is available for this article. See also the editorial by Bulte in this issue
Preclinical • Journal • CAR T-Cell Therapy
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SSTR (Somatostatin Receptor)
|
CD19 positive
3ms
Study of CD19-directed Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia (clinicaltrials.gov)
P1, N=60, Recruiting, St. Jude Children's Research Hospital | Trial completion date: Jan 2026 --> Jun 2027 | Trial primary completion date: Jan 2025 --> Jun 2026
Trial completion date • Trial primary completion date
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CD19 positive
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cyclophosphamide • fludarabine IV • CD19-CAR.CD45RA- negative T-cells
3ms
Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=44, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Mar 2025
Trial completion date • Trial primary completion date
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CD19 positive
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lenalidomide • Blincyto (blinatumomab)
3ms
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov)
P1, N=37, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
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CD19 positive
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cyclophosphamide • etoposide IV • fludarabine IV • Belrapzo (bendamustine RTD) • CD19 CAR T cells
4ms
Treatment strategies for relapse after CAR T-cell therapy in B cell lymphoma. (PubMed, Front Pediatr)
However, salvage therapies for relapsed large B-cell lymphoma after CART19 cell therapy have not been fully explored and are conducted based on clinicians' case-by-case decisions. In this review, we will focus on salvage therapies reported to date and discuss the management of relapsed/refractory large B-cell lymphomas after CART19 cell therapy.
Review • Journal • CAR T-Cell Therapy • IO biomarker
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CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • CD22 (CD22 Molecule)
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CD19 positive • CD19 expression
5ms
UHKT-CAR19-01: CART19 Cells Effects in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P1, N=10, Recruiting, Institute of Hematology and Blood Transfusion, Czech Republic | Trial completion date: Jun 2028 --> Jun 2025 | Trial primary completion date: Jun 2027 --> Dec 2024
Trial completion date • Trial primary completion date
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CD19 (CD19 Molecule)
|
CD19 positive • CD19 expression
5ms
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II (clinicaltrials.gov)
P1/2, N=90, Recruiting, Tanja Andrea Gruber | Not yet recruiting --> Recruiting
Enrollment open
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KMT2A (Lysine Methyltransferase 2A)
|
CD19 positive
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bortezomib • Blincyto (blinatumomab) • Zolinza (vorinostat) • dexamethasone • mitoxantrone • ziftomenib (KO-539) • mercaptopurine
5ms
Scalable generation of functional human iPSC-derived CAR-macrophages that efficiently eradicate CD19-positive leukemia. (PubMed, J Immunother Cancer)
In summary, our work provides insights into the seminal use and behavior of CAR-macrophages which are derived from various sources of stem cells, while introducing a unique technology for CAR-macrophage manufacturing, all dedicated to the clinical translation of CAR-macrophages within the field of anticancer immunotherapies.
Journal • IO biomarker
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CD19 (CD19 Molecule)
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CD19 positive • CD19 expression
5ms
Reprogramming of human γδ T cells by expression of an anti-CD19 TCR fusion construct (εTRuC) to enhance tumor killing. (PubMed, J Leukoc Biol)
Here, we express an anti-CD19 εTRuC in primary γδ T cells that were expanded using zoledronate (Zol) or concanavalin A. We show that the resulting εTRuC γδ T cells were reprogrammed to better recognize CD19-positive B cell tumors and-in case of the Zol-expanded cells-a CD19-expressing colon adenocarcinoma-derived cell line in vitro...Finally, addition of vitamin C promoted the recovery of larger γδ T cell numbers after lentiviral transduction, as used for the expression of the εTRuC. In conclusion, the generation and use of γδ εTRuC T cells might be a new approach for cancer immunotherapy.
Journal • IO biomarker
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CD19 (CD19 Molecule) • IL2RA (Interleukin 2 receptor, alpha) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
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CD19 positive • CD19 expression
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zoledronic acid
5ms
Chimeric Antigen Receptor T Cell Therapy for Acute Leukemia. (PubMed, Blood Cell Ther)
Tocilizumab and steroids are the major interventions for controlling cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)...The combination of ruxolitinib and steroids effectively controlled severe CRS without impeding CAR-T cell expansion...Switching targets and eliminating residual CD7+ CAR-T cells in the blood are key points for patients who relapse after CD7+ CAR-T cell therapy. CAR-T cell therapies for AML have not been investigated in a large-scale cohort, except for CD19-positive AML with the AML1-ETO fusion gene.
Journal • CAR T-Cell Therapy
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CD7 (CD7 Molecule)
|
CD19 positive
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Jakafi (ruxolitinib) • Actemra IV (tocilizumab)
5ms
New P1 trial • CAR T-Cell Therapy
|
CD19 positive
|
pCAR-19B
5ms
D7400C00006: A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=116, Recruiting, AstraZeneca | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
Trial completion date • Trial primary completion date
|
CD19 positive
|
AZD0486
5ms
Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL (clinicaltrials.gov)
P2, N=2, Active, not recruiting, University of Maryland, Baltimore | Trial completion date: Nov 2025 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Jun 2024
Trial completion date • Trial primary completion date • Minimal residual disease
|
CD81 (CD81 Molecule)
|
CD19 positive
|
Blincyto (blinatumomab)
5ms
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=36, Recruiting, C. Babis Andreadis | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
Trial completion date • Trial primary completion date • CAR T-Cell Therapy
|
CD19 positive
|
cyclophosphamide • fludarabine IV
5ms
Trial completion • Enrollment change
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
CD19 positive • BCL6 rearrangement • BCL2 rearrangement
|
Breyanzi (lisocabtagene maraleucel)
6ms
New P2 trial
|
CD19 (CD19 Molecule)
|
CD19 positive • CD19 expression
|
Tecartus (brexucabtagene autoleucel)
6ms
Phase I clinical study on the safety and effectiveness of ECAR-T (Enhanced receptor and chimeric antigen receptor - modified PD1-positive T cell) in the treatment of CD19-positive relapsed or refractory non-Hodgkin's lymphoma (ChiCTR2200058936)
P1, N=29, Recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University | Not yet recruiting --> Recruiting
Enrollment open
|
PD-1 (Programmed cell death 1)
|
CD19 positive • CD20 negative • PD-1 positive
|
Loqtorzi (toripalimab-tpzi)
6ms
Anti-CD19/CD22 Bispecific Chimeric Antigen Receptor(CAR)-T Cell Therapy for Measurable Residual Disease(MRD) Positive ALL (clinicaltrials.gov)
P1, N=19, Completed, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting --> Completed | Trial completion date: Aug 2022 --> Nov 2023 | Trial primary completion date: Aug 2022 --> Nov 2023
Trial completion • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Minimal residual disease
|
CD22 (CD22 Molecule)
|
CD19 positive • CD22 positive
|
cyclophosphamide • fludarabine IV • anti-CD19/CD22 CAR-T cells
6ms
Preclinical Efficacy of a Novel CD8-Targeted Fusosome for In Vivo CAR T Cell Therapy (ASH 2023)
SG299 is a CD8-targeted fusosome; a self-inactivating (SIN) lentiviral vector (LVV) pseudotyped with a CD8-targeted fusogen, which carries a transgene encoding a CD19-directed chimeric antigen receptor (CAR)...Finally, an assessment of donor-to-donor variability across five PBMC donors using a single lot of fusosome showed donor-specific variations in tumor control as measured by BLI but demonstrated a consistent protection from morbidity and mortality. Collectively, these studies demonstrate preclinical efficacy of our CD8/CD19CAR candidate, lot consistency and verify our ability to generate CD19-directed CAR T cells in vivo using a specifically targeted platform.
Preclinical • CAR T-Cell Therapy
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
CD19 positive
6ms
A Phase I Clinical Trial of Fully Human Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (ASH 2023)
Lymphodepletion consisted of cyclophosphamide 60mg/kg on day -6 and Fludarabine 25mg/m2/day on days -5 to -3...Two cases of CRS required no intervention, while the remaining cases received tocilizumab (n=4), steroids (n=2), and/or anakinra (n1)... As of 7/1/2023, a total of 13 patients were enrolled in Group A (NHL), and two patients were enrolled in Group B (B-ALL). Three patients in Group A withdrew consent or were withdrawn at the investigator's discretion due to new comorbid conditions before cell collection. Additionally, three patients were unable to receive CAR-T cell infusions due to disease progression, including two with Burkitt lymphoma.
Clinical • P1 data • CAR T-Cell Therapy
|
CD19 positive
|
cyclophosphamide • fludarabine IV • Actemra IV (tocilizumab) • Kineret (anakinra)
6ms
Development of Chimeric Antigen Receptor (CAR) T Cells Targeting MET in Lymphomas and Solid Tumors (ASH 2023)
(B) Cytotoxicity of MET-CAR against OCI-LY3 which is positive for MET but negative for CD19. E: T ratio is 10: 1.
IO biomarker
|
MET (MET proto-oncogene, receptor tyrosine kinase) • CD19 (CD19 Molecule) • CD69 (CD69 Molecule)
|
CD19 positive • MET expression • CD19 expression
6ms
Reinfusion of Varnimcabtagene Autoleucel (IMN-003A) in Patients with Relapsed Refractory B Cell Malignancies Is Feasible with Sustained Responses (ASH 2023)
B-ALL pt received Dasatinib, Inotuzumab and CNS prophylaxis. Preparative conditioning regimen for these 4 patients were: Fludarabine-Cyclophosphamide (n=1), with Rituximab (n=2) and Rituximab with Nivolumab (n=1)... Reinfusion of varnimcabtagene autoleucel (IMN-003A) is feasible, safe and well tolerated. Preparative conditioning regimen for reinfusion needs personalization guided by CAR persistence, disease biology (CD20, PDL1 expression) and haematological reserve. After reinfusion, prolonged B cell aplasia was observed with 100% ORR at D+28 in evaluable pts.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD20 (Membrane Spanning 4-Domains A1)
|
PD-L1 expression • CD19 positive
|
Opdivo (nivolumab) • dasatinib • Rituxan (rituximab) • cyclophosphamide • Besponsa (inotuzumab ozogamicin) • fludarabine IV • varnimcabtagene autoleucel (ARI-0001)