NCT05576181

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Fundamenta Therapeutics, Ltd. · Industry
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited

Interventions

Type	Name	Description
DRUG	ThisCART19A	ThisCART19A is a new type CAR-T therapy for patients with r/r B-ALL.
DRUG	Fludarabine Oral Tablet	Fludarabine is used for lymphodepletion.
DRUG	Cyclophosphamide	Cyclophosphamide is used for lymphodepletion.
DRUG	VP-16	VP-16 is used for lymphodepletion.
PROCEDURE	HSCT	Hematological stem cell transplantation

Timeline

• Start date: 2022-10-15
• Primary completion: 2025-01-22
• Completion: 2025-07-22
• First posted: 2022-10-12
• Last updated: 2022-10-12