NCT03935893

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers

Recruiting now Phase 2 Last updated 10 July 2025

What this trial tests

Phase 2 trial testing Tumor Infiltrating Lymphocytes (TIL) in Gastric Cancer in 240 participants. Currently enrolling.

Timeline

3 December 2019

Primary endpoint
30 June 2037

30 June 2038

Quick facts

Lead sponsor	Udai Kammula
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	3 December 2019
Primary completion	30 June 2037
Estimated completion	30 June 2038
Sites	1 location across United States

Drugs / interventions tested

• Tumor Infiltrating Lymphocytes (TIL) — full drug profile →
• Fludarabine + Cyclophosphamide combination

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Sarcoma — all drugs for Sarcoma →

Sponsor

Udai Kammula

Who can join

Adults 18 to 75, any sex, with Gastric Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 2 study to evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 3.) pancreatic, 4.) sarcoma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options by using the objective response rate (ORR).

Publications & conference data

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

1. T cells in health and disease.
   Sun L, Su Y, Jiao A, Wang X, et al · · 2023 · cited 717× · PMID 37332039 · DOI 10.1038/s41392-023-01471-y
2. Review of precision cancer medicine: Evolution of the treatment paradigm.
   Tsimberidou AM, Fountzilas E, Nikanjam M, Kurzrock R. · · 2020 · cited 475× · PMID 32251926 · DOI 10.1016/j.ctrv.2020.102019
3. Neoantigen T-Cell Receptor Gene Therapy in Pancreatic Cancer.
   Leidner R, Sanjuan Silva N, Huang H, Sprott D, et al · · 2022 · cited 406× · PMID 35648703 · DOI 10.1056/nejmoa2119662
4. Relationships Between Immune Landscapes, Genetic Subtypes and Responses to Immunotherapy in Colorectal Cancer.
   Picard E, Verschoor CP, Ma GW, Pawelec G. · · 2020 · cited 401× · PMID 32210966 · DOI 10.3389/fimmu.2020.00369
5. Sarcoma treatment in the era of molecular medicine.
   Grünewald TG, Alonso M, Avnet S, Banito A, et al · · 2020 · cited 230× · PMID 33047515 · DOI 10.15252/emmm.201911131
6. Immunotherapy efficacy on mismatch repair-deficient colorectal cancer: From bench to bedside.
   Lizardo DY, Kuang C, Hao S, Yu J, et al · · 2020 · cited 160× · PMID 33035640 · DOI 10.1016/j.bbcan.2020.188447
7. Current and emerging therapeutic approaches for colorectal cancer: A comprehensive review.
   Kumar A, Gautam V, Sandhu A, Rawat K, et al · · 2023 · cited 159× · PMID 37206081 · DOI 10.4240/wjgs.v15.i4.495
8. Current and future immunotherapeutic approaches in pancreatic cancer treatment.
   Farhangnia P, Khorramdelazad H, Nickho H, Delbandi AA. · · 2024 · cited 153× · PMID 38835055 · DOI 10.1186/s13045-024-01561-6