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)
BIOHENG THERAPEUTICS US LLC
54 participants
Oct 7, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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.
Exclusion Criteria10
- 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.
Interventions
CAR T cells
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07070219