TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia

TCR2 Therapeutics6 enrolled

Overview

TC-110 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human CD19, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex. This is a Phase 1/2 open-label study to evaluate the safety of autologous genetically engineered TC-110 T cells in patients with aggressive NHL (DLBCL, PMBCL, TFL), high-risk indolent NHL (including MCL), or adult ALL.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Hodgkin Lymphoma Acute Lymphoblastic Leukemia Diffuse Large B Cell Lymphoma Primary Mediastinal Large B Cell Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is \> 18 years of age at the time the Informed Consent is signed * Patient has agreed to abide by all protocol-required procedures, including study-related assessments, and management by the treating institution for the duration of the study and LTFU * Histologically confirmed NHL or ALL * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol * Patient must be fit for leukapheresis and have adequate venous access for cell collection * Patient must have evidence of CD19 expression * Prior CD19-directed CAR T therapy is allowed

Locations (3)

Colorado Blood Cancer Institute

Denver, Colorado, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Establish the recommended phase 2 dose (RP2D) for the NHL and ALL indications according to the observed adverse events, including potential dose-limiting toxicities (DLT).

Time frame: DLTs within 28 days post-treatment

To evaluate the efficacy of autologous genetically modified TC-110 T cells in adult patients with R/R NHL as determined by overall response rate (ORR)

Time frame: ORR at 3 months for NHL patients at 3 months

To evaluate the efficacy of autologous genetically modified TC-110 T cells in adult patients with R/R ALL as determined by overall response rate and Minimum Residual Disease (MRD) negativity rates

Time frame: ORR rate and MRD negativity rate for ALL patients at 3 months