A Study of CTD402 in T-ALL/LBL Patients

Launched by BIOHENG THERAPEUTICS US LLC · Jul 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CTD402 UCART for people with a type of blood cancer called T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL) that has come back after treatment or has not responded to previous treatments. The main goal is to find out if this treatment is safe and if it helps fight the cancer.

People who are 12 years or older, weigh at least 40 kilograms (about 88 pounds), and have T-ALL or LBL that has returned or not improved after at least two previous treatments may be eligible to join. Participants will receive a single infusion (a one-time dose given through the vein) of CTD402 on the first day of the study. After that, doctors will carefully watch how the cancer responds and will follow participants for up to two years to see how they do. If they continue in the study long-term, they may be followed for up to 15 years under a separate plan. It’s important to know that people with serious heart problems, active infections, or certain other health issues might not be able to take part. This trial is not yet open for new participants but aims to offer hope for those who have limited treatment options.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male or female, ≥ 12 years of age.
• • 2. Participants with body weight ≥ 40 kilogram.
• 3. Relapsed or refractory T-ALL/LBL is defined as one of the following:
• • 1. Relapsed or refractory disease after two or more lines of systemic therapy;
• • 2. The first relapse occurs within 12 months after first remission;
• • 3. Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
• • 4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
• • 5. Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
• • 6. Adequate organ function
• • 7. Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening.
• Key Exclusion Criteria:
• • 1. Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.
• • 2. Active central nervous system (CNS) involvement
• 3. Participants with following cardiac conditions will be excluded:
• • 1. History of heart failure New York Heart Association (NYHA) class III or IV;
• • 2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
• • 4. Primary immune deficiency.
• • 5. Presence of uncontrolled infections.
• • 6. Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
• • 7. Active or latent hepatitis B virus infection
• • 8. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.