A Phase I/II Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1.

NCT05881525 Phase 1 RECRUITING

New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.

Details

Lead sponsor	TCRCure Biopharma Ltd.
Phase	Phase 1
Status	RECRUITING
Enrolment	18
Start date	2023-06-01
Completion	2026-12

Conditions

• Advanced Solid Tumors

Interventions

• TC-N201 cells
• IL-2
• Fludarabine
• Cyclophosphamide
• Nab-paclitaxel

Primary outcomes

• Dose Limiting Toxicity or Maximum Tolerated Dose (MTD) — Day 28 after the first TC-N201 infusion
  Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality, and should be possibly related to TC-N201 cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication. MTD is defined as the highest dose at which ≤1 of 6 patients experienced a DLT or the highest dose level studied if DLTs are not observed at any of the dose levels.
• Overall response rate — Day 0 - Day 730
  The efficacy of TC-N201 will be assessed by the objective response rate (ORR) evaluated according to RECIST 1.1 and iRECIST. ORR is described as patients assessed with partial response (PR) and complete response (CR).
• Treatment-related adverse events as assessed by National Cancer Institute general terminology standard for adverse events (NCI CTCAE) v5.0 — Day 0 - Day 730
  The type, incidence and severity of adverse events include abnormal laboratory examination results with clinical significance after treatment, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory adverse events will be classified according to the CTCAE v5.0.

Countries

China