NCT07070219 · BIOHENG THERAPEUTICS US LLC
A Study of CTD402 in T-ALL/LBL Patients
(TENACITY-01)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female, ≥ 12 years of age.
- Participants with body weight ≥ 40 kilogram.
- Relapsed or refractory T-ALL/LBL is defined as one of the following:
- Relapsed or refractory disease after two or more lines of systemic therapy;
- The first relapse occurs within 12 months after first remission;
- Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
- The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
- Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
- Adequate organ function
- Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening. Key
Exclusion criteria
- Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.
- Active central nervous system (CNS) involvement
- Participants with following cardiac conditions will be excluded:
- History of heart failure New York Heart Association (NYHA) class III or IV;
- History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
- Primary immune deficiency.
- Presence of uncontrolled infections.
- Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
- Active or latent hepatitis B virus infection
- Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.
Where
- Palo Alto, California
- Denver, Colorado
- Chicago, Illinois
- Rochester, Minnesota
- New York, New York
- The Bronx, New York
- Nashville, Tennessee
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations