RecruitingInterventionalPhase 1/Phase 2

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)

NCT ID: NCT07070219Sponsor: BIOHENG THERAPEUTICS US LLCLast updated: 2026-02-05

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.

Detailed 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.

Arms & interventions

DrugCTD402 CAR T Cell Injection
CAR T cells

Outcome measures

Primary

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

Secondary

Characterize the cPK profile of CTD402
Time frame: 24 months

Eligibility criteria

Sex: AllAge: 12 Years and olderHealthy volunteers: No

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.

Study locations (8)

Stanford University

Palo Alto, California, 94304

Recruiting

Lori Muffly, MD · Contact

scicto-trialposting@stanford.edu

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Not Yet Recruiting

Luke Mountjoy, MD · Contact

University of Chicago

Chicago, Illinois, 60637

Not Yet Recruiting

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Not Yet Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 11101

Recruiting

Mark Geyer, MD · Contact

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, 10467

Recruiting

Alex Sica, MD · Contact

Sarah Cannon Research Insitute

Nashville, Tennessee, 37203

Recruiting

Haydar Frangoul, MD · Contact

844-482-4812

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Nitin Jain, MD · Contact

njain@mdanderson.org