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Study of alloCART-19 Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

NCT04173988 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of CD19-Directed Allogeneic Chimeric Antigen Receptor T- cell (alloCART-19)therapy in pediatric patients with relapsed/refractory acute lymphoblastic leukemia（ALL）.

Conditions

  • ALL, Childhood B-Cell

Interventions

GENETIC

alloCART-19

AlloCART-19 is an allogeneic CAR-T cell product targeting CD19. * For children with body weight ≤ 50 kg, dose range for dose escalation will be 0.5 - 5 × 10\^6 CAR+ cells/kg * For children with body weight \> 50 kg, dose range for dose escalation will be 0.25 - 2.5 × 10\^8 CAR+ cells.

DRUG

Cyclophosphamide

Chemotherapy for lymphodepletion

DRUG

Fludarabine

Chemotherapy for lymphodepletion

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • zhai xiaowen, PhD · PI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2024-10-20
Completion
2025-07-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04173988 on ClinicalTrials.gov