A Phase 1 interventional study of Dasatinib plus anti-CD19/CD22 CAR-T cells in Ph Positive ALL, CAR-T Cell and Dasatinib, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 1, Interventional, and Treatment
To evaluate the safety and efficacy of Dasatinib plus CD19/CD22 Bispecific CAR-T for the treatment of elderly Ph-positive lymphoblastic leukemia. Newly diagnosed Ph-positive patients will be given Dasatinib plus VP chemotherapy for induction treatment,if a hematologic complete remission was observed then a lymphocyte collection will be administrated to patients. Then chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells
Newly diagnosed ph-positive ALL patients over 60 and less than 70 years old will be enrolled. Patients will be given Dasatinib plus VP chemotherapy for induction remission treatment, if a hematologic complete remission was observed then a lymphocyte collection will be administrated to patients. Then chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.
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(5) Liver, kidney and cardiopulmonary functions meet the following requirements:
Exclusion Criteria:
(4) 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; Heart disease including the following condition
Administration with oral Dasatinib plus anti-CD19/ CD22 CAR-T cells in the elderly Ph-positive ALL patients.
Drug: Dasatinib plus anti-CD19/CD22 CAR-T cells
Dasatinib plus VP chemotherapy was administrated to newly diagnosed Ph-positive patients aged 55-70 years old,if hCR was achieved,autolymphocyte was collected,and anti-CD19/CD22 CAR-T cells infusion was administrated to patients followed by Fludarabine and Cyclophosphamide therapy
Number of patients achieving molecular CR
number of patients achieving molecular CR
Time frame: 3 months after infusion of Anti-CD19/CD22 CAR-T cells
OS for patients receiving infusion of anti-CD19/CD22 CAR-T cells
Overall survival for all patients enrolled
Time frame: 2-year OS
RFS for patients receiving infusion of anti-CD19/CD22 CAR-T cells
Relapse free survival for all patients enrolled
Time frame: 2-year RFS
Number of patients achieving molecular CR
number of patients achieving molecular CR after infusion of Anti-CD19/CD22 CAR-T cells
Time frame: 6 months after infusion of Anti-CD19/CD22 CAR-T cells
Plan to share: No
Started Mar 2021 (actual). Primary completion is estimated for Mar 2025, 48 months after the start.
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This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine →