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A Study of CTD402 in T-ALL/LBL Patients
Sponsor: BIOHENG THERAPEUTICS US LLC
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
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