Clinical Trials

Study Title: Phase I/II Study of Autologous T Cells Engineered Using the Sleeping Beauty System to Express T-Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors

Status: open to enrollment ( Identifier: NCT05194735)

Objectives for part 1:

  • To define the incidence of dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of T-Cell Receptor T cells (herein referred to as TCR-T cell drug product administered without IL-2 (Arm A) or with IL-2 (Arm B).

Arm A:

To define the incidence of DLT and the MTD of TCR-T cell drug product delivered as a single administration.
Arm B:
To determine the MTD/MAD/RP2D of TCR-T cell drug product delivered as a single administration followed by IL-2 administration.

  • To evaluate the feasibility of TCR-T cell drug product manufacturing.
  • To investigate translational hypotheses related to TCR-T cell persistence without IL-2 (Arm A) or with IL-2 (Arm B).

In order to be enrolled in this trial, patients characteristics include:

  1. Patients who have completed the HLA Typing and Tumor Neoantigen Identification Protocol (TCR001-002/screening protocol) and for whom a TCR(s) matching the subject’s somatic mutation(s) and HLA type.
  2. Patients who have previously received at least one line of standard systemic therapy for their advanced/metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment. Specifically:
    • Subgroup 1. Gynecologic cancers ovarian or endometrial:
    • Subgroup 2. Colorectal cancer
    • Subgroup 3. Pancreatic cancer
    • Subgroup 4. Non-small cell lung cancer (NSCLC)
    • Subgroup 5. Cholangiocarcinoma