MDA-TIL / Iovance Biotherap, UT MD Anderson Cancer Center - LARVOL DELTA

NCI-2018-01509: Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=16 | Terminated | Sponsor: M.D. Anderson Cancer Center | N=60 ➔ 16

Enrollment change • Carcinosarcoma • Colorectal Adenocarcinoma • Colorectal Cancer • Hepatology • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Refractory Ovarian Cancer • Sarcoma • Solid Tumor

NCI-2018-01509: Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=60 | Terminated | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jan 2025 ➔ Aug 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2025 ➔ Aug 2024; Lack of Efficacy

Trial completion date • Trial primary completion date • Trial termination • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Refractory Ovarian Cancer • Sarcoma • Solid Tumor • CD27 • CD28 • CD8

NCI-2018-01509: Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | N=27 ➔ 60 | Trial primary completion date: Jan 2024 ➔ Jan 2025

Enrollment change • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Refractory Ovarian Cancer • Sarcoma • Solid Tumor • CD27 • CD28 • CD8

Efficacy and safety of autologous expanded tumor infiltrating lymphocytes (TILs) in multiple solid tumors. (ASCO 2022) - P2 | "Ex vivo TIL expansion and manufacturing was conducted at the MD Anderson TIL lab under conditions that included IL2 and 41BB stimulation (using urelumab). All patients received a lymphodepletion regimen consisting of cyclophosphamide 60mg/kg days -7 and -6 and fludarabine 25mg/m2 days -5 through day -1, followed by infusion of pooled ex-vivo expanded TIL... Generation of TIL at a single academic center for CRC, PDAC and OVA is feasible and treatment is associated with no new safety signals. For these tumor types, further research is required to identify host factors associated with resistance to TIL therapy and optimize manufacturing processes to create more effective TIL cell therapy."

Clinical • Hematological Disorders • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • ENTPD1

Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2; N=27; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Sep 2021 ➔ Jan 2025; Trial primary completion date: Sep 2021 ➔ Jan 2024

Clinical • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Refractory Ovarian Cancer • Sarcoma • Solid Tumor

Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2; N=27; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Recruiting ➔ Active, not recruiting; N=60 ➔ 27

Clinical • Enrollment change • Enrollment closed • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor