NeoTIL in Advanced Solid Tumors

Status Active, not recruiting

Clinical Trial Summary

Single center, single arm pilot trial to test the feasibility, safety and efficacy of NeoTIL-ACT combined with low-dose irradiation (LDI) in patients with advanced, recurrent or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by LDI, and then ACT utilizing ex vivo expanded TIL, enriched for tumor antigen specificity (NeoTIL), in combination with high dose Interleukin-2 (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, safety, and efficacy of NeoTIL-ACT in combination with LDI in patients with advanced, recurrent or metastatic solid tumors, as categorized in two molecularly defined cohorts. 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 from for five days, and cyclophosphamide ffor two days. Low-dose irradiation (LDI) will be administered once, to tumor lesions using tomotherapy. Patients will receive NeoTIL infusion intravenously followed by high dose IL-2 administration every eight hours, for a maximum of fourteen doses. Supportive care will be given as needed during the whole treatment period. Patients achieving a stable disease, partial response or complete response after NeoTIL-ACT treatment will then enter a clinical follow-up period for 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04643574
Study type	Interventional
Source	Centre Hospitalier Universitaire Vaudois
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	March 9, 2021
Completion date	November 2027

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	`NCT03992326` - Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in 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