This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) Bridging Hematopoietic Stem Cell Transplantation 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 safety and efficacy of ThisCART19A Bridging Hematopoietic Stem Cell Transplantation 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
ThisCART19A is a new type CAR-T therapy for patients with r/r B-ALL.
Fludarabine is used for lymphodepletion.
Cyclophosphamide is used for lymphodepletion.
Dose limited toxicity(DLT) observation in patient with B-ALL in each dose level during dose escalation and dose expansion stage
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Time frame: 28 days
Overall Complete Response (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) within 3 months
OCR rate within 3 months: percentage of participants achieving CR+CRi within 3 months after CAR-T cell infusion.
Time frame: 3 months
Minimum Residual Disease (MRD) Negative Remission Rate
MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. Percentage of participants with MRD negative remission was reported.
Time frame: 3 months
Duration of response(DOR) during dose escalation stage and expansion stage
DOR was defined as the time from first CR or CRi to relapse or any death in the absence of documented relapse.
Time frame: 24 months
RFS (Relapse-free Survival)
RFS is defined as the time from the date of ThisCART19A infusion to the date of disease relapse or death from any cause.
Time frame: 24 months
EFS (Event-free Survival)
EFS is defined as the time from the date of ThisCART19A infusion to the date of disease relapse, progression, genetic relapse or death from any cause.
Time frame: 24 months
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VP-16 is used for lymphodepletion.
Hematological stem cell transplantation
OS (Overall Survival)
OS is defined as the time from the date of ThisCART19A infusion to the date of death from any cause.
Time frame: 24 months