A Study of CTD402 in T-ALL/LBL Patients

Last updated: December 29, 2025
Sponsor: BIOHENG THERAPEUTICS US LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Leukemia

Treatment

CTD402 CAR T Cell Injection

Clinical Study ID

NCT07070219
BHCT-CTD402-201
  • Ages > 12
  • All Genders

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 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.

Eligibility Criteria

Inclusion

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:

  4. Relapsed or refractory disease after two or more lines of systemic therapy;

  5. The first relapse occurs within 12 months after first remission;

  6. Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior toscreening period.

  7. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologicevaluation or evidence of extramedullary disease at screening.

  8. Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligiblehaploidentical donor (HID) or syngeneic donors.

  9. Adequate organ function

  10. Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants <

  1. at screening.

Exclusion

Key Exclusion Criteria:

  1. Participants with concomitant genetic syndromes associated with bone marrow failurestates or any other known bone marrow failure syndrome.

  2. Active central nervous system (CNS) involvement

  3. Participants with following cardiac conditions will be excluded:

  4. History of heart failure New York Heart Association (NYHA) class III or IV;

  5. History of myocardial infarction, cardiovascular angioplasty or stenting,unstable angina, or other serious heart diseases within 12 months ofenrollment.

  6. Primary immune deficiency.

  7. Presence of uncontrolled infections.

  8. Known history of infection with the human immunodeficiency virus (HIV); hepatitis Cvirus and syphilis.

  9. Active or latent hepatitis B virus infection

  10. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.

Study Design

Total Participants: 54
Treatment Group(s): 1
Primary Treatment: CTD402 CAR T Cell Injection
Phase: 1/2
Study Start date:
October 07, 2025
Estimated Completion Date:
December 30, 2028

Study Description

TENACITY-01 is a single-arm, open-label, multi-center, Phase 1b/2 study to assess the safety and efficacy of CTD402 in adolescent (≥ 12 to 17 years) and adult participants with relapsed/refractory (r/r) T-ALL/LBL. Approximately 18 participants will be enrolled in the Phase 1b portion of the study to evaluate the safety and establish the RP2D of CTD402, with approximately 18 participants receiving CTD402 at RP2D. Approximately 36 participants will be enrolled in the Phase 2 portion of the study to further confirm the efficacy and safety of CTD402.

Both the phase 1b and phase 2 portions will consist of the following sequential phases: screening (up to 2 weeks), lymphodepletion period (within 7 days prior to treatment), CTD402 treatment (a single dose), primary follow-up period (up to 2 years). Once a participant receives the first dose of lymphodepleting chemotherapy regimen, the participant will be considered enrolled into the study.

Long term follow-up will be conducted under a separate protocol until 15 years following CTD402 infusion for survival, toxicity, RCR monitoring, and secondary malignancy.

Connect with a study center

  • Stanford University

    Palo Alto 5380748, California 5332921 94304
    United States

    Active - Recruiting

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 11101
    United States

    Site Not Available

  • Montefiore Einstein Comprehensive Cancer Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Active - Recruiting

  • Sarah Cannon Research Insitute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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