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

A Single-Arm, Open-Label, Multi-Center, Phase 1b/ 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)

This trial will test whether a single infusion of CTD402 UCART can be safe and shrink cancer in people age 12 and older with relapsed or refractory T‑cell acute lymphoblastic leukemia or lymphoblastic lymphoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Bioheng Therapeutics Us LLC (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Palo Alto, California and 7 other locations)
• Trial ID: NCT07070219 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 12 or older weighing at least 40 kg with relapsed/refractory T‑ALL or T‑LBL meeting the protocol's relapse criteria, with adequate organ function and acceptable performance status.

Not a fit: Patients with genetic bone marrow failure syndromes, inadequate organ function, poor performance status, or who do not meet the trial's age, weight, or relapse criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, CTD402 could induce remissions and provide durable responses for patients with relapsed or refractory T‑ALL/LBL who have few effective options.

How similar studies have performed: Allogeneic UCART approaches have shown encouraging early responses in some hematologic cancers, but CAR‑T for T‑cell leukemias remains experimentally challenging and has limited large‑scale success so far.

Eligibility criteria

Key Inclusion Criteria:

1. Male or female, ≥ 12 years of age.
2. Participants with body weight ≥ 40 kilogram.
3. Relapsed or refractory T-ALL/LBL is defined as one of the following:

   1. Relapsed or refractory disease after two or more lines of systemic therapy;
   2. The first relapse occurs within 12 months after first remission;
   3. Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
5. Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
6. Adequate organ function
7. 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 this trial is running

Palo Alto, California and 7 other locations

• Stanford University — Palo Alto, California, United States (Recruiting)
• Colorado Blood Cancer Institute — Denver, Colorado, United States (Not_yet_recruiting)
• University of Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
• Mayo Clinic - Rochester — Rochester, Minnesota, United States (Not_yet_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)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Jan Davidson-Moncada, MD, PhD

Conditions Acute Lymphocytic Leukemia Refractory; Lymphoma, Lymphoblastic; CAR-T Therapy; relapsed/refractory