Actively Recruiting
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics of CTD402 in Patients Aged 12 and Older with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Led by BIOHENG THERAPEUTICS US LLC · Updated on 2026-02-05
54
Participants Needed
8
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CTD402 UCART in patients aged 12 and older with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LBL). This open-label, single-arm, multi-center study includes adolescents and adults and aims to establish the recommended dose and confirm treatment effects. The study is sponsored by BIOHENG THERAPEUTICS US LLC and includes detailed safety and response evaluations. Participants will receive a single infusion of CTD402 after a lymphodepletion period within 7 days prior to treatment. The study includes screening lasting up to 2 weeks, followed by the treatment day and a primary follow-up period lasting up to 2 years. After the initial study period, participants will be enrolled in a separate long-term follow-up protocol for up to 15 years to monitor survival, toxicity, relapse, and secondary malignancies. During the study, participants will have assessments for tumor response using NCCN criteria for T-ALL and Lugano 2014 criteria for T-LBL. Safety monitoring will be conducted for 24 months, including evaluation of the cellular pharmacokinetic profile of CTD402. The study involves regular clinical visits, laboratory testing, and monitoring for adverse events. Participant involvement is planned for up to 2 years with extended follow-up to track long-term outcomes.
CONDITIONS
Brief Title
A Study of CTD402 in T-ALL/LBL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 12 years or older
- Body weight of at least 40 kilograms
- Relapsed or refractory T-ALL/LBL after two or more systemic treatments, or first relapse within 12 months after first remission, or relapse after allogeneic HSCT (at least 100 days before screening)
- Bone marrow lymphoblasts 5% or higher or evidence of extramedullary disease at screening
- Have an eligible HLA-matched related or unrelated donor, haploidentical donor, or syngeneic donors
- Adequate organ function
- Karnofsky performance status 60 or higher for participants 16 years or older, or Lansky performance status 60 or higher for participants younger than 16
You will not qualify if you...
- Genetic syndromes associated with bone marrow failure or other bone marrow failure syndromes
- Active central nervous system involvement
- History of serious heart conditions including heart failure NYHA class III or IV, myocardial infarction, cardiovascular procedures, or unstable angina within 12 months prior to enrollment
- Primary immune deficiency
- Uncontrolled infections
- Known history of HIV, hepatitis C, or syphilis infection
- Active or latent hepatitis B infection
- Positive Epstein-Barr virus, Cytomegalovirus DNA, or IgM at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Within 7 days prior to treatment
Participants receive lymphodepleting chemotherapy prior to treatment with CTD402.
1 visit (in-person)
Duration - Single dose treatment period
Participants receive a single dose of CTD402 CAR T Cell Injection.
1 infusion visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety, efficacy, and pharmacokinetics following treatment.
Visits scheduled over 2 years for response evaluation and safety monitoring
Trial Site Locations
Total: 8 locations
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Not Yet Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
4
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 11101
Actively Recruiting
6
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States, 10467
Actively Recruiting
7
Sarah Cannon Research Insitute
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jan Davidson-Moncada, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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