Clinical Trials Logo
  1. Home
  2. Solid Tumor, Adult
  3. NCT03992326

Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:
Phase Ib Study To Assess The Feasibility And Safety Of Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes In Advanced Solid Tumors

Clinical Trial Summary

Single center, single arm phase Ib trial to test the feasibility and safety of Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) combined with low-dose irradiation in patients with advanced or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by low dose irradiation (LDI), and then ACT utilizing ex vivo expanded TILs in combination with high dose IL-2 (optional, depending on patient's tolerance). LDI will be administered once to metastatic lesions using tomotherapy.

Clinical Trial Description

The objective of the trial is to define the feasibility and safety of TIL-ACT in combination with low-dose irradiation (LDI) in patients with advanced or metastatic solid tumors. Study treatment will begin with intravenous (IV) non-myeloablative (NMA) lymphodepleting chemotherapy composed by fludarabine and cyclophosphamide. Both treatments will be started on the same day. Fludarabine will be administered for five days, and cyclophosphamide for two days. Low-dose irradiation (LDI) will be then administered once, to up to 20 measurable tumor lesions using tomotherapy. TIL infusion will be performed intravenously followed by high dose IL-2 administration every eight hours, for a maximum of eight doses. Supportive care will be given as needed during the whole treatment period. Patients achieving a stable disease, partial response or complete response after TIL-ACT treatment will then enter a follow-up period for 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03992326
Study type Interventional
Source Centre Hospitalier Universitaire Vaudois
Contact
Status Terminated
Phase Phase 1
Start date September 1, 2019
Completion date March 5, 2021
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04551885 - FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors Phase 1
Completed NCT05054348 - First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Recruiting NCT06088004 - Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05055609 - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors Phase 1
Completed NCT04020185 - Safety and Efficacy Study of IMSA101 in Refractory Malignancies Phase 1/Phase 2
Withdrawn NCT05071846 - MVX-ONCO-2 in Advanced Solid Tumors Phase 1
Recruiting NCT05607199 - A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics Phase 1
Active, not recruiting NCT04552288 - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies Phase 2
Active, not recruiting NCT06026254 - A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial Phase 1
Recruiting NCT06032845 - Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Solid Tumors (CASTLE-11) Phase 2
Recruiting NCT06144671 - GT201 Injection For The Treatment Of Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06398418 - R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors Phase 1
Recruiting NCT05276284 - Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy Phase 1/Phase 2
Recruiting NCT04121442 - Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04221204 - A Monotherapy in Subjects With Advanced Solid Tumors Phase 1
Terminated NCT05435339 - A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy Phase 1/Phase 2
Recruiting NCT04981119 - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Recruiting NCT06075849 - Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent Phase 1
Recruiting NCT04092673 - Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies Phase 1/Phase 2