Actively Recruiting
A Study of CTD402 in T-ALL/LBL Patients
Led by BIOHENG THERAPEUTICS US LLC · Updated on 2026-02-05
54
Participants Needed
8
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official 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
- Diagnosis of relapsed or refractory T-ALL or T-LBL defined by one of the following:
- Disease relapse or resistance after two or more prior systemic therapies
- First relapse within 12 months after first remission
- Relapse after allogeneic hematopoietic stem cell transplant (HSCT) with at least 100 days elapsed before screening
- Bone marrow lymphoblasts 5% or greater or evidence of extramedullary disease at screening
- Availability of eligible HLA-matched related or unrelated donor, haploidentical donor, or syngeneic donor
- Adequate organ function
- Karnofsky performance status of 60 or higher for participants aged 16 or older, or Lansky performance status of 60 or higher for participants younger than 16 at screening
You will not qualify if you...
- Presence of genetic syndromes associated with bone marrow failure or other bone marrow failure syndromes
- Active involvement of the central nervous system (CNS)
- History of severe heart failure (NYHA class III or IV)
- History within 12 months of serious heart conditions including myocardial infarction, angioplasty, stenting, unstable angina, or other serious heart diseases
- Primary immune deficiency
- Presence of uncontrolled infections
- Known history of infection with HIV, hepatitis C virus, or syphilis
- Active or latent hepatitis B virus infection
- Positive Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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