Phase
Condition
Lymphoma
Leukemia
Treatment
CTD402 CAR T Cell Injection
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
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 toscreening period.
The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologicevaluation or evidence of extramedullary disease at screening.
Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligiblehaploidentical donor (HID) or syngeneic donors.
Adequate organ function
Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants <
- at screening.
Exclusion
Key Exclusion Criteria:
Participants with concomitant genetic syndromes associated with bone marrow failurestates 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 ofenrollment.
Primary immune deficiency.
Presence of uncontrolled infections.
Known history of infection with the human immunodeficiency virus (HIV); hepatitis Cvirus and syphilis.
Active or latent hepatitis B virus infection
Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.
Study Design
Study Description
Connect with a study center
Stanford University
Palo Alto 5380748, California 5332921 94304
United StatesActive - Recruiting
University of Chicago
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 11101
United StatesSite Not Available
Montefiore Einstein Comprehensive Cancer Center
The Bronx 5110266, New York 5128638 10467
United StatesActive - Recruiting
Sarah Cannon Research Insitute
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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