Anti-CD19/CD22 Bispecific Chimeric Antigen Receptor（CAR)-T Cell Therapy for Measurable Residual Disease(MRD) Positive ALL
NCT ID: NCT03919526
Last Updated: 2023-12-08
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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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2019-08-11
2023-11-01
Brief Summary
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Detailed Description
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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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anti-CD19/CD22 CAR-T cells
Administration with anti-CD19/ CD22 CAR-T cells in the MRD-positive ALL patients.
anti-CD19/CD22 CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
Interventions
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anti-CD19/CD22 CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
Eligibility Criteria
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Inclusion Criteria
* (2)18 to 70 Years Old, Male and female;
* (3) Expected survival \> 12 weeks;
* (4) ECOG score 0-2;
* (5) Bone marrow examination clearly diagnosed as B-cell acute lymphoblastic leukemia and who met one of the following conditions:
1. Recurrent patients who achieves MRD-positive CR or CRi after standard therapy;
2. Those who achieves CR, but failed to achieve MRD-negative after at least 2 courses of consolidation therapy;
3. For Ph-positive ALL patients, a history of at least one TKI application is required in addition to two standard chemotherapy treatments
* (6) The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
* (7) Liver, kidney and cardiopulmonary functions meet the following requirements:
1. Creatinine is in the normal range;
2. Left ventricular ejection fraction \>50%;
3. Baseline oxygen saturation\>92%;
4. Total bilirubin ≤ 2×ULN;
5. ALT and AST ≤ 2.5×ULN;
* (8) Able to understand and sign the Informed Consent Document.
Exclusion Criteria
* (2) Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
* (3) Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
* (4) Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
* (5) Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
* (6) Received CAR-T treatment or other gene therapies before enrollment;
* (7) Patients with symptoms of central nervous system;
* (8) Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
* (9) The investigators consider other conditions unsuitable for enrollment.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Xianmin Song, MD
principal investigator
Principal Investigators
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Xianmin Song, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SHSYXY-CAR-T MRD+ALL
Identifier Type: -
Identifier Source: org_study_id