NCT03526185

A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes

Terminated EARLY_PHASE1 Last updated 25 July 2022

What this trial tests

EARLY_PHASE1 trial testing Tumor Infiltrating Lymphocytes in Metastatic Melanoma in 6 participants. Terminated before completion.

Timeline

6 February 2018

Primary endpoint
1 December 2020

1 December 2020

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	6 February 2018
Primary completion	1 December 2020
Estimated completion	1 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Tumor Infiltrating Lymphocytes — full drug profile →
• Nivolumab and Ipilimumab (nivolumab-and-ipilimumab) — full drug profile →

Conditions studied

• Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

Yale University

Who can join

18 and older, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To determine the feasibility and safety of administering a regimen of TIL/IL-2, using a cell product manufactured in the Yale Advanced Cell Therapy Laboratories, in subjects with metastatic melanoma who are not responding or have progressed after receiving prior therapy with a PD-1/PD-L1 antagonist used alone or in combination with anti-CTLA-4. Additionally, a second cohort of patients with metastatic melanoma who are not responding or have progressed after receiving prior therapy with a PD-1/PD-L1 antagonist alone or in combination with anti-CTLA-4 will receive anti-PD-1 and anti-CTLA-4 therapy with Nivolumab and Ipilimumab.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
   Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449
2. Tumor microenvironmental influences on dendritic cell and T cell function: A focus on clinically relevant immunologic and metabolic checkpoints.
   Hargadon KM. · · 2020 · cited 47× · PMID 32508018 · DOI 10.1002/ctm2.37
3. The Comprehensive "Omics" Approach from Metabolomics to Advanced Omics for Development of Immune Checkpoint Inhibitors: Potential Strategies for Next Generation of Cancer Immunotherapy.
   Yoon SJ, Lee CB, Chae SU, Jo SJ, et al · · 2021 · cited 13× · PMID 34203237 · DOI 10.3390/ijms22136932
4. Longitudinal single-cell analysis of a patient receiving adoptive cell therapy reveals potential mechanisms of treatment failure.
   Qu R, Kluger Y, Yang J, Zhao J, et al · · 2022 · cited 6× · PMID 36514045 · DOI 10.1186/s12943-022-01688-5
5. Transforming cancer immunotherapy: integration of distinct immune-based approaches as redefined dual immunotherapy with potential third-sensitizer.
   Wang Y, Jiang C, Zhou H, Han R. · · 2025 · cited 3× · PMID 41024300 · DOI 10.1186/s40164-025-00705-9