RecruitingPhase 1Phase 2NCT07070219

A Study of CTD402 in T-ALL/LBL Patients

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)

Sponsor

BIOHENG THERAPEUTICS US LLC

Enrollment

54 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Lymphoma, Lymphoblastic Acute Lymphocytic Leukemia Refractory

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called CTD402 in patients with T-cell leukemia or lymphoma (T-ALL/LBL) whose cancer has come back or stopped responding to other treatments. The goal is to evaluate the safety and effectiveness of this investigational therapy. **You may be eligible if...** - You are 12 years of age or older and weigh at least 40 kg (about 88 lbs) - You have T-cell leukemia or lymphoma that has relapsed or not responded to at least two prior treatment regimens - OR your cancer relapsed within 12 months of completing first-line treatment - OR your cancer relapsed after a bone marrow transplant **You may NOT be eligible if...** - You have not previously tried at least two treatments - You have certain serious health conditions or organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCTD402 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07070219

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