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Recruiting Phase 1/2

A Study of CTD402 in T-ALL/LBL Patients

NCT07070219 · tracked via the Priya Life Science USA tracker
Sponsor
Imviva Bio
Phase
Phase 1/2
Started
2025-10-07
Last updated
2026-08-19

Condition(s) studied

Acute Lymphocytic Leukemia RefractoryLymphoma, Lymphoblastic

Investigational drug(s) / intervention(s)

CTD402 CAR T Cell Injection

CTD402 CAR T Cell Injection: CAR T cells

Study 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 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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Safety Profile — 24 months
    Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease
  • Response Evaluation — 24 months
    Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee

Trial sites (9)

FacilityCityRegionStatus
Stanford University Palo Alto California Recruiting
Colorado Blood Cancer Institute Denver Colorado Withdrawn
University of Chicago Chicago Illinois Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Montefiore Einstein Comprehensive Cancer Center The Bronx New York Recruiting
Sarah Cannon Research Insitute Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Royal Prince Alfred Sydney New South Wales Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07070219 on ClinicalTrials.gov ↗ ← All trials in the USA