A Study of CTD402 in T-ALL/LBL Patients

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.

NCT Number	NCT07070219
Lead Sponsor	BIOHENG THERAPEUTICS US LLC
Conditions	Acute Lymphocytic Leukemia Refractory, Lymphoma, Lymphoblastic
Enrollment	54 participants
Start Date	2025-10-07
Primary Completion	2028-09-30 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-05