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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:
    6d
    Ipilimumab With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Melanoma Mets Pts (clinicaltrials.gov)
    P=N/A, N=13, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 --> Sep 2025
    Trial completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600 • BRAF wild-type
    |
    Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    10d
    CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=1, Terminated, Celularity Incorporated | N=52 --> 1 | Trial completion date: Feb 2025 --> Feb 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Feb 2023 --> Feb 2024; for business reasons
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • cyclophosphamide • CYNK-101 • fludarabine IV • mesna • Proleukin (aldesleukin)
    12d
    Type 2 responses determine skin rash during recombinant interleukin-2 therapy. (PubMed, J Immunotoxicol)
    One of the drugs inducing CADRs is aldesleukin, a recombinant interleukin-2 (recIL-2) originally approved to treat malignant melanoma and metastatic renal cell carcinoma which frequently led to skin rashes when applied in high doses for anti-cancer therapy...Together, this hypothetic irAOP forms a basis to clarify possible cellular and molecular interactions leading to recIL-2-induced skin rash. This might be used to adapt existing or develop new test systems to help predict and prevent cutaneous side effects in future IL-2-based or similar therapies.
    Review • Journal
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin)
    1m
    TIL Therapy for Metastatic Renal Cell Carcinoma (clinicaltrials.gov)
    P1, N=5, Completed, Inge Marie Svane | Unknown status --> Completed
    Trial completion • Metastases
    |
    IL2 (Interleukin 2)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    1m
    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)
    2ms
    IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis (clinicaltrials.gov)
    P1, N=34, Not yet recruiting, Indapta Therapeutics, INC.
    New P1 trial
    |
    IL2 (Interleukin 2)
    |
    cyclophosphamide • fludarabine IV • mesna • IDP-023 • Proleukin (aldesleukin) • Ocrevus (ocrelizumab)
    2ms
    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)
    2ms
    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)
    3ms
    STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, City of Hope Medical Center
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    3ms
    NCI-2018-01758: Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1, N=4, Terminated, Roswell Park Cancer Institute | Trial completion date: Jan 2027 --> Jun 2024 | Active, not recruiting --> Terminated; Lack of funding
    Trial completion date • Trial termination
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    melphalan • Proleukin (aldesleukin)
    4ms
    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)
    5ms
    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
    |
    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
    5ms
    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
    5ms
    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)
    7ms
    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
    7ms
    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)
    7ms
    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)
    7ms
    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
    7ms
    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
    7ms
    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)
    8ms
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Active, not recruiting, National Cancer Institute (NCI)
    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)
    8ms
    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)
    8ms
    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)
    8ms
    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)
    9ms
    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)
    9ms
    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)
    9ms
    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)
    10ms
    NCI-2018-01758: Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1, N=4, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Jan 2024 --> Jan 2027
    Trial completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    melphalan • Proleukin (aldesleukin)
    10ms
    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
    10ms
    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
    10ms
    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
    10ms
    Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov)
    P1, N=210, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
    10ms
    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
    10ms
    Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov)
    P1, N=210, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
    11ms
    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)
    11ms
    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
    11ms
    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)
    11ms
    Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI... (clinicaltrials.gov)
    P2, N=102, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • Young TIL • ondansetron
    11ms
    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)
    11ms
    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
    12ms
    To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, Inge Marie Svane
    New P1 trial • Metastases
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • ADP-TILIL7
    12ms
    Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients (clinicaltrials.gov)
    P1/2, N=8, Suspended, National Cancer Institute (NCI) | N=110 --> 8 | Recruiting --> Suspended
    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)