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RECRUITING
NCT07070219
PHASE1/PHASE2

A Study of CTD402 in T-ALL/LBL Patients

Sponsor: BIOHENG THERAPEUTICS US LLC

View on ClinicalTrials.gov

Summary

The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients. Participants with relapsed/refractory T-ALL/LBL over the age of 12 will be eligible to participate. Participants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL. Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.

Official title: A Single-Arm, Open-Label, Multi-Center, Phase 1b/ 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-10-07

Completion Date

2028-12-30

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

CTD402 CAR T Cell Injection

CAR T cells

Locations (8)

Stanford University

Palo Alto, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

University of Chicago

Chicago, Illinois, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Sarah Cannon Research Insitute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States