This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.
This is a phase 1, single-center, nonrandomized, open-label, dose-escalation and dose expansion study to evaluate the safety and efficacy of ThisCART19A in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy 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
12
ThisCART19A is a new type CAR-T therapy for patients with r/r B Cell Malignancy .
Fludarabine is used for lymphodepletion.
Cyclophosphamide is used for lymphodepletion.
Henan cancer hospital
Zhengzhou, Henan, China
Dose limited toxicity(DLT) observation in patient with B Cell Malignancy in each dose level during dose escalation 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
Objective Response Rate within 3 months during dose expansion stage
For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve Complete Response (CR) or Complete Response With Incomplete Hematologic Recovery (CRi); for lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).
Time frame: 3 months
Minimum Residual Disease (MRD) Negative Remission Rate within 3 months during dose expansion stage
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/CRi or PR to relapse or any death in the absence of documented relapse.
Time frame: 24 months
Relapse-free Survival (RFS)
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
Event-free Survival (EFS)
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.
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VP-16 is used for lymphodepletion.
Time frame: 24 months
Overall Survival (OS)
OS is defined as the time from the date of ThisCART19A infusion to the date of death from any cause.
Time frame: 24 months