A Study of CTD402 in T-ALL/LBL Patients

NCT07070219 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BHCT-CTD402-201
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Acute Lymphocytic Leukemia Refractory; Lymphoma, Lymphoblastic

Keywords

CAR-T Therapy; relapsed/refractory

Outcome Measures

Primary Outcomes (2)

• Safety Profile

  Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease

  24 months

• Response Evaluation

  Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee

  24 months

Secondary Outcomes (1)

• Characterize the cPK profile of CTD402

  24 months

Study Arms (1)

CTD402 Cell Infusion

EXPERIMENTAL

Drug: CTD402 CAR T Cell Injection

Interventions

CTD402 CAR T Cell Injection DRUG

CAR T cells

CTD402 Cell Infusion

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥ 12 years of age.
• Participants with body weight ≥ 40 kilogram.
• Relapsed or refractory T-ALL/LBL is 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.
• The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
• Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
• Adequate organ function
• Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening.

You may not qualify if:

• Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.
• Active central nervous system (CNS) involvement
• Participants with following cardiac conditions will be excluded:
• History of heart failure New York Heart Association (NYHA) class III or IV;
• History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
• Primary immune deficiency.
• Presence of uncontrolled infections.
• Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
• Active or latent hepatitis B virus infection
• Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.

Sponsors & Collaborators

• BIOHENG THERAPEUTICS US LLC: lead

Study Sites (8)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

NOT YET RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 11101, United States

RECRUITING

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, 10467, United States

RECRUITING

Sarah Cannon Research Insitute

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jan Davidson-Moncada, MD, PhD

CONTACT

917-573-8538; clinicaltrials@bioheng.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 17, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)