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DRUG:

Proleukin (aldesleukin)

i
Other names: rIL-2, recombinant human interleukin-2, 125-L-Serine-2-133-interleukin 2, r-serHuIL-2
Company:
Clinigen, Iovance Biotherap, Merck (MSD), Novartis, Roche
Drug class:
IL-2 stimulant, CD122 agonist
Related drugs:
4d
Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies (clinicaltrials.gov)
P2, N=6, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
Trial completion date • Trial primary completion date • Metastases
|
CTAG1B (Cancer/testis antigen 1B)
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
15d
New P1 trial
|
IL2 (Interleukin 2)
|
cyclophosphamide • fludarabine IV • mesna • IDP-023 • Proleukin (aldesleukin) • Ocrevus (ocrelizumab)
25d
Adoptive Cell Therapy Across Cancer Diagnoses (clinicaltrials.gov)
P1/2, N=25, Completed, Inge Marie Svane | Unknown status --> Completed
Trial completion
|
IL2 (Interleukin 2)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
1m
Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients with Stage III-IV Melanoma (clinicaltrials.gov)
P1, N=34, Active, not recruiting, M.D. Anderson Cancer Center | N=15 --> 34 | Trial completion date: Jun 2025 --> Oct 2027 | Trial primary completion date: Jun 2024 --> Oct 2027
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
2ms
New P1 trial
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
2ms
Trial completion date • Trial termination
|
CTAG1B (Cancer/testis antigen 1B)
|
melphalan • Proleukin (aldesleukin)
3ms
Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov)
P1/2, N=47, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2024 --> Jul 2025
Trial completion date • Combination therapy • Epigenetic controller • Metastases
|
mTOR (Mechanistic target of rapamycin kinase)
|
Jingzhuda (entinostat) • Proleukin (aldesleukin)
4ms
Discovery and development of ANV419, an IL-2/anti-IL-2 antibody fusion protein with potent CD8+ T and natural killer cell-stimulating capacity for cancer immunotherapy. (PubMed, MAbs)
ANV419 also enhances the NK cell killing capacity and increases tumor growth inhibition when used alongside trastuzumab in a Her-2+ xenograft mouse model...These data support the clinical development of ANV419 in solid tumors and hematological malignancies as monotherapy and in combination with checkpoint inhibitors or agents that induce antibody-dependent cellular cytotoxicity. ANV419 is currently in Phase 1/2 clinical development and may provide cancer patients with a wider therapeutic window than aldesleukin.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL2 (Interleukin 2)
|
Herceptin (trastuzumab) • Proleukin (aldesleukin) • ANV419
4ms
EVICTION-2: Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=100, Recruiting, ImCheck Therapeutics | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • Proleukin (aldesleukin) • ICT01
4ms
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov)
P1, N=30, Recruiting, Christian Hinrichs | Trial primary completion date: Sep 2025 --> Sep 2026
Trial primary completion date • Gene therapy
|
cyclophosphamide • Proleukin (aldesleukin)
6ms
CLN-617 retains IL-2 and IL-12 in injected tumors to drive robust and systemic immune-mediated antitumor activity. (PubMed, Cancer Immunol Res)
However, the only approved human IL-2 therapy, Proleukin, is rarely used in the clinic due to systemic toxicities, and no IL-12 product has been approved to date due to severe dose-limiting toxicities. We found that IT administration of a murine surrogate of CLN-617, mCLN-617, eradicated established treated and untreated tumors in syngeneic models, significantly improved response to anti-PD1 checkpoint therapy, and generated a robust abscopal response dependent on cellular immunity and antigen cross-presentation. CLN-617 is being evaluated in a clinical trial in patients with advanced solid tumors (NCT06035744).
Journal
|
IL2 (Interleukin 2)
|
Proleukin (aldesleukin) • CLN-617
6ms
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
P1/2, N=136, Recruiting, Aulos Bioscience, Inc. | Trial completion date: Jan 2025 --> Sep 2025 | Trial primary completion date: Oct 2024 --> Aug 2025
Trial completion date • Trial primary completion date • Metastases
|
Proleukin (aldesleukin) • imneskibart (AU-007)
6ms
Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors (clinicaltrials.gov)
P1/2, N=180, Active, not recruiting, Alaunos Therapeutics | Trial completion date: Mar 2029 --> Nov 2024 | Trial primary completion date: Dec 2025 --> Nov 2024
Trial completion date • Trial primary completion date • IO biomarker
|
IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
|
Proleukin (aldesleukin)
6ms
A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=20, Not yet recruiting, University of Southern California | Trial completion date: Apr 2027 --> Aug 2027 | Initiation date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2026 --> Aug 2026
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTAG1B (Cancer/testis antigen 1B)
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
6ms
NCI-2018-00918: LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas (clinicaltrials.gov)
P2, N=30, Active, not recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jun 2024 --> Jun 2025 | Trial completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8) • CD28 (CD28 Molecule) • CD27 (CD27 Molecule)
|
CD8 expression • CD28 expression
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • LN-145 • LN-145-S1
6ms
Aerosolized Aldesleukin in Treating Patients With Lung Metastases (clinicaltrials.gov)
P1, N=70, Active, not recruiting, M.D. Anderson Cancer Center | Phase classification: P1/2 --> P1 | Trial completion date: Apr 2024 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2026
Phase classification • Trial completion date • Trial primary completion date
|
Proleukin (aldesleukin)
7ms
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
|
Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
7ms
NK4AML: Natural Killer-cell Therapy for Acute Myeloid Leukemia (clinicaltrials.gov)
P1/2, N=23, Recruiting, Radboud University Medical Center | Trial completion date: Sep 2023 --> Sep 2025 | Trial primary completion date: Sep 2023 --> Sep 2025
Trial completion date • Trial primary completion date • Combination therapy
|
IL2 (Interleukin 2)
|
cyclophosphamide • Proleukin (aldesleukin) • oNKord (inaleucel)
7ms
Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov)
P1, N=15, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
7ms
CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma (clinicaltrials.gov)
P2, N=16, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Apr 2024 | Trial primary completion date: Jan 2025 --> Apr 2024
Trial completion • Trial completion date • Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2) • MLANA (Melan-A)
|
BRAF mutation • BRAF V600
|
Yervoy (ipilimumab) • cyclophosphamide • Proleukin (aldesleukin)
8ms
Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R (clinicaltrials.gov)
P2, N=60, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date
|
cytarabine • etoposide IV • idarubicin hydrochloride • Proleukin (aldesleukin) • busulfan • Neupogen (filgrastim)
8ms
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
P1/2, N=136, Recruiting, Aulos Bioscience, Inc. | N=69 --> 136 | Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Jul 2024 --> Oct 2024
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
Proleukin (aldesleukin) • imneskibart (AU-007)
8ms
Non-Viral TCR Gene Therapy (clinicaltrials.gov)
P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=210 --> 0 | Trial completion date: Dec 2029 --> Mar 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2028 --> Mar 2024
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • IO biomarker • Gene therapy • Metastases
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
8ms
Trial completion date
|
CTAG1B (Cancer/testis antigen 1B)
|
melphalan • Proleukin (aldesleukin)
9ms
TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
P1, N=15, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
9ms
Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)
P1, N=15, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting | Initiation date: May 2024 --> Jan 2024
Enrollment open • Trial initiation date
|
IL2 (Interleukin 2)
|
Proleukin (aldesleukin) • CIML NK
9ms
CIML NK Cells With Venetoclax for AML (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Active, not recruiting
Enrollment closed
|
Venclexta (venetoclax) • Proleukin (aldesleukin) • CIML NK
9ms
Enrollment open
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
9ms
A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=20, Not yet recruiting, University of Southern California | Trial completion date: Nov 2026 --> Apr 2027 | Initiation date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2025 --> Apr 2026
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTAG1B (Cancer/testis antigen 1B)
|
HER-2 negative • PGR negative
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
9ms
New P1 trial
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
10ms
Immunotherapy for the Treatment of Advanced Solid Tumor (clinicaltrials.gov)
P1/2, N=40, Recruiting, Tongji Hospital | Not yet recruiting --> Recruiting
Enrollment open
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
10ms
TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
P1, N=15, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
New P1 trial
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
10ms
Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer (clinicaltrials.gov)
P2, N=84, Active, not recruiting, Providence Health & Services | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Metastases
|
IL2 (Interleukin 2)
|
Proleukin (aldesleukin)
10ms
Trial completion date • Trial primary completion date • Metastases
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • Young TIL • ondansetron
10ms
Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
P2, N=153, Active, not recruiting, St. Jude Children's Research Hospital | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date • Metastases
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • humanised dinutuximab (Hu14.18K322A)
10ms
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer (clinicaltrials.gov)
P2, N=332, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Dec 2023 --> Dec 2024
Trial primary completion date • Metastases
|
Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • Young TIL
10ms
New P1 trial • Metastases
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • ADP-TILIL7
11ms
Enrollment change • Trial suspension • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
|
KRAS mutation • NRAS mutation • KRAS G12V • HRAS mutation • KRAS G12 • NRAS G12 • HLA-A*11 • NRAS G12V
|
cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
11ms
Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma (clinicaltrials.gov)
P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date • Metastases
|
BRAF V600E • BRAF V600
|
Zelboraf (vemurafenib) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
11ms
Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma (clinicaltrials.gov)
P=N/A, N=19, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date • Metastases
|
IFNG (Interferon, gamma)
|
cyclophosphamide • Proleukin (aldesleukin)
11ms
Trial initiation date
|
IL2 (Interleukin 2)
|
Proleukin (aldesleukin) • CIML NK
11ms
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma (clinicaltrials.gov)
P3, N=168, Active, not recruiting, The Netherlands Cancer Institute
Trial completion date • Metastases
|
Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)