Status:
UNKNOWN
Efficacy and Safety Evaluation of IM19 CAR-T Cell Therapy for MRD+ After Transplantation
Lead Sponsor:
Beijing Immunochina Medical Science & Technology Co., Ltd.
Conditions:
Leukemia
Eligibility:
All Genders
3-65 years
Phase:
NA
Brief Summary
Efficacy study about donor derived CD19-target T cell to treat B-ALL post hematopoietic stem cell transplantation
Detailed Description
Allogeneic hematopoietic stem cell transplantation (allo-hsct) for the treatment of refractory recurrent acute b-lymphoblastic leukemia (b-all), the overall survival rate of 3 years after transplantat...
Eligibility Criteria
Inclusion
- To be aged 3 to 65 years
- It was consistent with the diagnosis of CD19+ B-All with MRD+ in allo- hsct transplantation
- The immunotyping was determined to be CD19+ B-All
- The T lymphocytes in the subjects were 100% donor T lymphocytes
- No chemotherapy or antibody treatment was received 2 weeks before cell therapy
- Left ventricular ejection fraction (LVEF) ≥50% and centerless inclusion were diagnosed by echocardiography
- The subjects had no pulmonary active infection
- Blood oxygen saturation at the fingertips ≥ 92%
- Estimated survival of \>3 months
- ECOG physical condition level 0\~1
Exclusion
- Unwilling to accept IM19 CAR-T cell therapy, do not agree to signInformed consent of subject
- Subjects are allergic to the components of cellular products
- Total serum bilirubin ≥ 2.0mg/dl、Serum albumin \< 35g/L、ALT and AST were more than 3 times of the upper limit of the normal range. Blood creatinine ≥ 2.0mg/dl;Platelet \< 20 x 109 / L
- Subjects had activity level II-IV aGVHD, or activityModerate to severe cGVHD
- The subjects had a severe failure to control the infection
- Subject with known central nervous system leukemia (CNS2 or CNS3)
- Subjects were treated with CAR T cells or DLT after transplantation
- The subjects developed bone marrow failure syndrome after allo-hsct transplantation
- The subjects had previously received other gene treatments
- The subjects had a history of alcohol, drug use or mental illness
- Subjects were enrolled in any other clinical investigator within 1 month prior to screening
- Female subjects: 1) were pregnant/lactating, or 2) had a pregnancy plan during the study period,Or 3) fertile and unable to use effective contraception
- The researchers believe there are other conditions that may not be appropriate for the study
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04336501
Start Date
January 1 2019
End Date
December 1 2021
Last Update
December 17 2020
Active Locations (1)
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1
Peking University people's hospita
Beijing, Beijing Municipality, China, 000000