CTD402 for relapsed or refractory T-ALL and T-LBL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TENACITY-01 is a single-arm, open-label, multi-center Phase 1b/2 program testing CTD402 in adolescents (≥12 years) and adults with relapsed or refractory T‑ALL/LBL. The study uses a sequential schedule of screening, lymphodepleting chemotherapy, a single CTD402 infusion on Day 0, and a primary follow-up period of up to 2 years, with separate long‑term follow-up extending to 15 years. The Phase 1b portion will define the recommended Phase 2 dose and includes an initial dose-finding cohort, and the Phase 2 portion will enroll additional participants to further confirm safety and anti-tumor activity. An independent review committee will evaluate anti-tumor responses using NCCN criteria for T‑ALL and Lugano 2014 criteria for T‑LBL.

Why it matters

Who can join: the full rules

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.

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• Mayo Clinic - Rochester
  Rochester, Minnesota, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Montefiore Einstein Comprehensive Cancer Center
  The Bronx, New York, United States Recruiting
• Sarah Cannon Research Insitute
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Jan Davidson-Moncada, MD, PhD
• Email: clinicaltrials@imvivabio.com
• Phone: 917-573-8538

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.