AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

A Study of CTD402 in T-ALL/LBL Patients

RecruitingPhase 1, Phase 2Ages 1 Year - anyAllImviva Bio
💬

In plain words

What the trial is, and whether it could suit you

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 1 year 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key Inclusion Criteria: 1. Male or female, ≥ 1 year of age. 2. Participants with body weight ≥ 40 kilogram. 3. A) Relapsed or refractory T-ALL/LBL or MRD positive 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. B) Minimal Residual Disease (MRD) positive T-ALL/LBL is defined as evidence of MRD, defined as \< 5% blasts in bone marrow but ≥ 1 cancer cell in 1,000 cells determined by NGS ClonoSEQ® and/or other regionally acceptable methodologies (e.g., EuroMRD guidelines). 4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening. 5. Adequate organ function 6. ECOG of 2 or less or 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.
💊

What it tests

  • CTD402 CAR T Cell Injection
📍

Where

9 sites
Stanford University
Palo Alto, United States
Colorado Blood Cancer Institute
Denver, United States
University of Chicago
Chicago, United States
Mayo Clinic - Rochester
Rochester, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, United States
Sarah Cannon Research Insitute
Nashville, United States
MD Anderson Cancer Center
Houston, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy