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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.

After patients achieve MRD- remissions through ThisCART19A, they will subsequently receive hematological stem cell transplantations.

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

ThisCART19A

Fludarabine Oral Tablet

Cyclophosphamide is used for lymphodepletion.

VP-16

HSCT

Jun Li, Ph.D

Yongping Song, Ph.D

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.

Safety and Efficacy of ThisCART19A Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia

A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia

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

OCR rate within 3 months: percentage of participants achieving CR+CRi within 3 months after CAR-T cell infusion.

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 or CRi 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
Safety and Efficacy of ThisCART19A Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia	NCT05576181	Allogeneic, CAR...	ThisCART19A Fludarabine Ora... Cyclophosphamid... VP-16 HSCT	14 Years - 75 Years	Fundamenta Therapeutics, Ltd.
Safety and Efficacy of ThisCART19A Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia	NCT05576181	Allogeneic, CAR...	ThisCART19A Fludarabine Ora... Cyclophosphamid... VP-16 HSCT	14 Years - 75 Years	Fundamenta Therapeutics, Ltd.
Safety and Efficacy of ThisCART19A Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia	NCT05576181	Allogeneic, CAR...	ThisCART19A Fludarabine Ora... Cyclophosphamid... VP-16 HSCT	14 Years - 75 Years	Fundamenta Therapeutics, Ltd.
Safety and Efficacy of ThisCART19A Bridging Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia	NCT05576181	Allogeneic, CAR...	ThisCART19A Fludarabine Ora... Cyclophosphamid... VP-16 HSCT	14 Years - 75 Years	Fundamenta Therapeutics, Ltd.

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