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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TCR2 Therapeutics
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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