Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
54 participants
INTERVENTIONAL
2025-10-07
2028-12-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CTD402 Cell Infusion
CTD402 CAR T Cell Injection
CAR T cells
Interventions
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CTD402 CAR T Cell Injection
CAR T cells
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
12 Years
ALL
No
Sponsors
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BIOHENG THERAPEUTICS US LLC
INDUSTRY
Responsible Party
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Locations
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Stanford University
Palo Alto, California, United States
University of Chicago
Chicago, Illinois, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Sarah Cannon Research Insitute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Lori Muffly, MD
Role: primary
Mark Geyer, MD
Role: primary
Alex Sica, MD
Role: primary
Haydar Frangoul, MD
Role: primary
Nitin Jain, MD
Role: primary
Other Identifiers
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BHCT-CTD402-201
Identifier Type: -
Identifier Source: org_study_id