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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Phase 1/2 Trial of TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Acute Lymphoblastic Leukemia (ALL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323657
• Other study ID #: TCR2-19-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 27, 2020
• Est. completion date: February 24, 2023

Study information

• Verified date: March 2023
• Source: TCR2 Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Diffuse Large B Cell Lymphoma
• Follicular Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle Cell Lymphoma
• Non Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Primary Mediastinal Large B Cell Lymphoma

Intervention

Drug:
• TC-110 T Cells
TC-110 T Cells
• Fludarabine
Flu/Cy Lymphodepletion
• Cyclophosphamide
Flu/Cy Lymphodepletion

Locations

Country	Name	City	State
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
TCR2 Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		DLTs within 28 days post-treatment
Primary	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)		ORR at 3 months for NHL patients at 3 months
Primary	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		ORR rate and MRD negativity rate for ALL patients at 3 months