This is a phase 1, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) bridging to HSCT in patients with refractory or relapsed B cell acute lymphoblastic leukemia (r/r B-ALL).
This is a phase 1, single-center, nonrandomized, open-label, dose-escalation study to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A bridging to HSCT in patients with CD19 positive r/r B-ALL and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
In this study, allogeneic anti-CD19 CAR T cells (ThisCART19A) infusion is used as a bridge therapy to hematopoietic stem cell transplantation to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia. Lymphodepletion conditioning before CAR T cell infusion consists of fludarabine, CTX and VP-16.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGORR
Overall response rate
Time frame: 4 week
MRD Negativity
MRD Negativity is assessed utilizing multicolor flow cytometry to detect leukemia cells with a sensitivity of 10\^ (-4).
Time frame: 4 week
CR
Complete response
Time frame: 2 year
CRi
CR with incomplete hematologic recovery
Time frame: 2 year
CRh
CR with partial hematological recovery
Time frame: 2 year
BFBM
Blast-free hypoplastic or aplastic bone marrow
Time frame: 2 year
PR
Partial response
Time frame: 2 year
DOR
Duration of response
Time frame: 2 year
LFS
Leukemia-free survival
Time frame: 2 year
OS
Overall survival
Time frame: 2 year
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