Proleukin (aldesleukin) / Clinigen, Novartis, Iovance Biotherap - LARVOL DELTA

Complete tumor regression of metastatic epithelial cancer following T cell receptor (TCR)-T cell therapy (SITC 2025) - P2 | "Treatment consisted of conditioning chemotherapy with cyclophosphamide and fludarabine followed by a one-time infusion of up to 50 billion E7 T cells and adjuvant high-dose systemic aldesleukin...Complete responses occurred in a patient with esophageal cancer previously treated with 3 agents, including pembrolizumab, and in a patient with anal cancer previously treated with 5 agents, including nivolumab...The findings indicate that engineered T cell therapy can mediate complete regression of treatment-refractory metastatic epithelial cancers. Continued investigation of this treatment is warranted.Trial Registration This trial was registered on clinicaltrials.gov, trial number NCT05686226.Ethics Approval This study was approved by the WCG IRB; approval number CINJ 192204."

IO biomarker • Metastases • Anal Carcinoma • Esophageal Cancer • Hematological Malignancies • Oncology • Solid Tumor • HLA-A

TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | N=29 ➔ 18

Enrollment change • Enrollment closed • Melanoma • Oncology • Solid Tumor • BRAF

Targeting the intracellular immune checkpoint CISH with CRISPR-Cas9-edited T cells in patients with metastatic colorectal cancer: a first-in-human, single-centre, phase 1 trial. (PubMed, Lancet Oncol) - P1/2 | "These results support the safety and potential antitumour activity of inhibiting the immune checkpoint CISH through the administration of neoantigen-reactive CISH-knockout TILs, with implications for patients with advanced metastatic cancers refractory to checkpoint inhibitor immunotherapies, and provide the first evidence that a novel intracellular checkpoint can be targeted with therapeutic effect."

Journal • P1 data • Anorexia • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Infectious Disease • Microsatellite Instability • Oncology • Solid Tumor • Targeted Protein Degradation • MSI

A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=101 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2029 ➔ Mar 2031 | Trial primary completion date: Oct 2029 ➔ Mar 2031

Enrollment open • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Christian Hinrichs | Trial completion date: Dec 2028 ➔ Dec 2030 | Trial primary completion date: Sep 2026 ➔ Sep 2028

Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Estrogen Receptor Positive Breast Cancer • Gastric Cancer • Gene Therapies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

(RIOT 4A): Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: David Bartlett, MD | Trial completion date: Dec 2037 ➔ Apr 2038 | Initiation date: Mar 2026 ➔ Jun 2026 | Trial primary completion date: Dec 2032 ➔ Apr 2033

First-in-human • Trial completion date • Trial initiation date • Trial primary completion date • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Respiratory Diseases • Solid Tumor

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=56 | Terminated | Sponsor: ImCheck Therapeutics, an Ipsen company | Completed ➔ Terminated; The study was terminated based on sponsor decision unrelated to safety or efficacy. The study met the key primary and secondary endpoints, however two patients were receiving treatment at the decision point, preventing protocol-defined completion.

Trial termination • Colorectal Cancer • Melanoma • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Solid Tumor

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2R? Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=159 | Recruiting | Sponsor: Aulos Bioscience, Inc. | Trial completion date: Jun 2026 ➔ Feb 2027 | Trial primary completion date: Jun 2026 ➔ Feb 2027

First-in-human • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF

Efficacy of anti-GD2 antibody immunotherapy with filgrastim and teceleukin versus standard treatment with sargramostim, aldesleukin and isotretinoin in children with high-risk neuroblastoma. (PubMed, Int J Clin Oncol) - "Our results suggest that the efficacy of the alternative regimen containing G-CSF is comparable to that of the ANBL0032 regimen, providing a rationale for further evaluation in a phase III trial."

Journal • Hematological Disorders • Infectious Disease • Neuroblastoma • Oncology • Solid Tumor • Transplantation • CSF2

Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer (clinicaltrials.gov) - P1 | N=12 | Suspended | Sponsor: David Wald | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Colon Cancer • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Rectal Adenocarcinoma • Solid Tumor

A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=101 | Not yet recruiting | Sponsor: AstraZeneca

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Mayo Clinic | Trial completion date: Apr 2030 ➔ Jun 2029 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer (clinicaltrials.gov) - P2 | N=285 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Mar 2028 ➔ Mar 2029 | Trial primary completion date: Mar 2027 ➔ Mar 2028

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Estrogen Receptor Positive Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

PERTIL-01: A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: East Metropolitan Health Service, Australia

Checkpoint inhibition • New P2 trial • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor

Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: The Methodist Hospital Research Institute

New P1/2 trial • Alzheimer's Disease • CNS Disorders • Dementia • IL2

Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers (clinicaltrials.gov) - P1/2 | N=124 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2028 ➔ Jan 2030 | Trial primary completion date: Jan 2027 ➔ Jan 2029

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor

Autologous Tumor Infiltrating Lymphocytes With Interleukin-2 for the Treatment of Locally Advanced, Recurrent or Metastatic Gastrointestinal Stromal Tumors (clinicaltrials.gov) - P2 | N=59 | Not yet recruiting | Sponsor: Joal Beane

New P2 trial • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Oncology • Sarcoma

A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab (clinicaltrials.gov) - P2 | N=53 | Recruiting | Sponsor: National Cancer Institute (NCI) | N=170 ➔ 53

Enrollment change • Melanoma • Oncology • Solid Tumor

Imneskibart + low-dose subcutaneous IL-2 ± nivolumab in patients with CPI-refractory cutaneous melanoma: Promising results from an ongoing phase 1/2 study. (ASCO 2026) - P1/2 | "Funded by Aulos Bioscience Clinical Trial Registration Number: NCT05267626 Background: Imneskibart (AU-007) is an AI designed monoclonal antibody binding to interleukin-2 (IL-2) preventing binding to CD25 in the trimeric IL-2 receptor (IL-2 R), while allowing engagement with the dimeric IL-2R, CD122/CD132...Both cohorts receive subcutaneous (SC) 135K IU/kg aldesleukin dose on Day 1 of first cycle with additional doses of aldesleukin administered at the beginning of each cycle until at least a partial response (PR) is obtained... Compelling anti-tumor activity is observed with imneskibart + IL-2, with a strong emerging signal of enhanced activity with the nivolumab combination in pts with melanoma refractory to doublet CPI therapy. Imneskibart + IL-2–associated Treg reduction likely drives the high disease control rate, supporting durable benefit with prolonged treatment exposure and PFS."

Clinical • P1/2 data • Cutaneous Melanoma • Melanoma • Solid Tumor • CD8 • FCGR2A • FCGR2B • IL2 • IL2RA • IL2RG

A phase 1/2 dose-escalation/expansion study of REGN10597 (anti–PD-1–IL2Rα-IL2) in patients with advanced solid tumors. (ASCO 2026) - P1/2 | "Aldesleukin, an approved recombinant high-dose IL-2 therapy, has shown complete and durable responses in some cases; however, high-dose IL-2 is associated with severe toxicity, including vascular leak syndrome and pulmonary edema. Secondary endpoints for both phases include additional efficacy measures (best overall response, duration of response, disease control rate, time to response, and progression-free survival, all per RECIST 1.1), and pharmacokinetics and immunogenicity of REGN10597. Trial enrollment for the dose escalation phase began on October 1, 2024; as of January 27, 2026, 22 patients have been enrolled."

Clinical • First-in-human • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Melanoma • Oncology • Respiratory Diseases • Solid Tumor • IL2 • IL2RA

ANEMIL: Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment (clinicaltrials.gov) - P1/2 | N=2 | Terminated | Sponsor: University Hospital, Bordeaux | Completed ➔ Terminated; target number of inclusion not reached

Trial termination • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology • HP

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 | Recruiting | Sponsor: University of Southern California | Suspended ➔ Recruiting | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment open • IO biomarker • Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTAG1B • ER • HER-2 • PD-L1 • PGR

19-C-0017: Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients (clinicaltrials.gov) - P1/2 | N=5 | Terminated | Sponsor: National Cancer Institute (NCI) | Completed ➔ Terminated; Study was closed due to lack of accrual and study outcomes overlapped with another protocol's eligibility.

IO biomarker • Trial termination • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Rectal Cancer • Solid Tumor • ALK • HRAS • KRAS • NRAS • PD-L1

ProbeTILity: A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: Curacell Holding AB

First-in-human • Trial initiation date • Colorectal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor