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

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 | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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 | Completed | Sponsor: City of Hope Medical Center | Active, not recruiting ➔ Completed

Trial completion • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Essential Thrombocythemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers (clinicaltrials.gov) - P1 | N=36 | Terminated | Sponsor: National Cancer Institute (NCI) | Completed ➔ Terminated; Site plans to become a site for a multicenter study of this therapy

IO biomarker • Trial termination • Gene Therapies • Lung Cancer • Oncology • Solid Tumor

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 | Not yet recruiting | Sponsor: Curacell Holding AB

New P1/2 trial • Colorectal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer (clinicaltrials.gov) - P2 | N=27 | Completed | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies (clinicaltrials.gov) - P2 | N=6 | Active, not recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Nov 2026 ➔ Nov 2027 | Trial primary completion date: Nov 2025 ➔ Nov 2026

Trial completion date • Trial primary completion date • Oncology • CTAG1B

Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors (clinicaltrials.gov) - P1/2 | N=8 | Terminated | Sponsor: Alaunos Therapeutics | N=180 ➔ 8 | Active, not recruiting ➔ Terminated; Funding

Enrollment change • IO biomarker • Trial termination • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Gynecologic Cancers • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma

T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=85 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Oct 2027 | Trial primary completion date: Oct 2025 ➔ Oct 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

AZD6750: Design and Efficacy of a CD8-guided IL-2 That Enhances CD8 T Cell Function (SITC 2025) - "This approach potentially limits the side effects of Aldesleukin, typically attributed to the broad effects of IL-2R signalling, which should result in a safer, more effective IL-2 that has the potential to provide benefit to larger numbers of patients.Methods In vitro, proliferation of human PBMCs and antigen-specific tumor cytolysis were evaluated after treatment with AZD6750, Aldesleukin or an unguided-IL-2 mutein. Studies were performed in accordance with the UK Animal (Scientific Procedures) Act 1986 and the EU Directive 86/609, under a UK Home Office Project License, using guidelines outlined by Workman and colleagues and the UKCCR guidance. All patient samples were obtained with written informed consent and studies were conducted in accordance with recognized ethical guidelines (Declaration of Helsinki) and were approved by the East of England - Cambridge East Research Ethics Committee (HTA license number 12109)."

Clinical • Oncology • CD8 • FCGR2A • FCGR2B • IFNG • IL2 • IL2RA • IL2RG

Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma (clinicaltrials.gov) - P2 | N=17 | Completed | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Completed

Trial completion • Melanoma • Oncology • Solid Tumor

Phase 2 Trial of TIL Therapy for Metastatic Uveal Melanoma: Evaluating Cellular Potency and Tumor Transcriptomic Predictors of Response (SITC 2025) - P2 | "Patients received non-myeloablative lymphodepletion with cyclophosphamide and fludarabine, followed by infusion of TIL and high-dose interleukin-2...The median number of prior metastatic therapies was two, including checkpoint blockade in 61% and tebentafusp in 32% of patients...Integration of transcriptomic biomarkers such as UMIS to identify metastases harboring potent TIL may optimize patient selection and improve outcomes.Acknowledgements Aldesleukin was provided by Clinigen Limited and Iovance Biotherapeutics.Trial Registration NCT03467516Ethics Approval Patients gave informed consent prior to trial participation in accordance with the Declaration of Helsinki. This trial was reviewed and approved by the University of Pittsburgh Institutional Review Board (Approval CR19110103-018).Abstract 598 Figure 1Request permissionsWaterfall plot of clinical responses in patients with metastatic uveal melanoma after TIL therapy (NCT03467516">NCT03467516)Abstract 598..."

Metastases • P2 data • Eye Cancer • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • CD8

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

Phase 2 trial of TIL therapy for metastatic uveal melanoma: Evaluating cellular potency and tumor transcriptomic predictors of response (SITC 2025) - P2 | "Patients received non-myeloablative lymphodepletion with cyclophosphamide and fludarabine, followed by infusion of TIL and high-dose interleukin-2...The median number of prior metastatic therapies was two, including checkpoint blockade in 61% and tebentafusp in 32% of patients...Integration of transcriptomic biomarkers such as UMIS to identify metastases harboring potent TIL may optimize patient selection and improve outcomes.Acknowledgements Aldesleukin was provided by Clinigen Limited and Iovance Biotherapeutics.Trial Registration NCT03467516Ethics Approval Patients gave informed consent prior to trial participation in accordance with the Declaration of Helsinki. This trial was reviewed and approved by the University of Pittsburgh Institutional Review Board (Approval CR19110103-018).Abstract 598 Figure 1Request permissionsWaterfall plot of clinical responses in patients with metastatic uveal melanoma after TIL therapy (NCT03467516">NCT03467516)Abstract 598..."

Metastases • P2 data • Eye Cancer • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • CD8

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

Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD) (clinicaltrials.gov) - P2 | N=41 | Active, not recruiting | Sponsor: University of Oxford | Trial completion date: Sep 2022 ➔ Sep 2026

Trial completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients (clinicaltrials.gov) - P2 | N=29 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Aug 2025 ➔ Mar 2026

Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma (clinicaltrials.gov) - P=N/A | N=19 | Completed | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Aug 2025

Trial completion • Trial completion date • Melanoma • Oncology • Solid Tumor

Ipilimumab With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Melanoma Mets Pts (clinicaltrials.gov) - P=N/A | N=13 | Completed | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Completed

Trial completion • Melanoma • Oncology • Solid Tumor • BRAF

(RIOT 4A): Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: David Bartlett, MD

New P1 trial • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Respiratory Diseases • Solid Tumor

Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Nov 2026 ➔ Nov 2027 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • Transplantation

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=159 | Recruiting | Sponsor: Aulos Bioscience, Inc. | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Aug 2025 ➔ Jun 2026

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

Quadruple Immunotherapy for Neuroblastoma (clinicaltrials.gov) - P2 | N=29 | Recruiting | Sponsor: Hong Kong Children's Hospital | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced Gastrointestinal Malignancies (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: National Cancer Institute (NCI) | N=65 ➔ 0 | Trial completion date: Jun 2033 ➔ Sep 2025 | Suspended ➔ Withdrawn | Trial primary completion date: Jun 2029 ➔ Sep 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Tumor mutational burden • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Pancreatic Cancer • Small Intestinal Carcinoma • Solid Tumor

E7 TCR T Cells for Human Papillomavirus-Associated Cancers (clinicaltrials.gov) - P1/2 | N=219 | Completed | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jul 2025 | Trial primary completion date: Dec 2025 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Gene Therapies • Gynecologic Cancers • Gynecology • Infectious Disease • Oncology • Solid Tumor • Vulvar Cancer • HLA-A

To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Inge Marie Svane | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor