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

NCT05576181 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-10-12

No results posted yet for this study

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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Fundamenta Therapeutics, Ltd.

    lead INDUSTRY

Principal Investigators

  • Yongping Song, Ph.D · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2025-01-22
Completion
2025-07-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05576181 on ClinicalTrials.gov