Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Etoposide

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Etoposide phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

In this study, allogeneic anti-CD19 CAR T cell (ThisCART19A) infusion is used to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia.

ThisCART19A is a new type CAR-T therapy for patients with r/r B Cell Malignancy .

ThisCART19A

Fludarabine Pill

Cyclophosphamide is used for lymphodepletion.

VP-16 Protocol

Keshu zhou, Dr.

Jun Li, Ph.D

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.

Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy

A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 (ThisCART19A) in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy

DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.

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).

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.

DOR was defined as the time from first CR/CRi or PR to relapse or any death in the absence of documented relapse.

RFS is defined as the time from the date of ThisCART19A infusion to the date of disease relapse or death from any cause.

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.

OS is defined as the time from the date of ThisCART19A infusion to the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy	NCT05640713	Allogeneic, CAR...	ThisCART19A Fludarabine Pil... Cyclophosphamid... VP-16 Protocol	18 Years - 75 Years	Henan Cancer Hospital
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy	NCT05640713	Allogeneic, CAR...	ThisCART19A Fludarabine Pil... Cyclophosphamid... VP-16 Protocol	18 Years - 75 Years	Henan Cancer Hospital

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