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Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL

NCT03937544 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-29

No results posted yet for this study

Summary

This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia

Conditions

  • Relapsed B Acute Lymphoblastic Leukaemia
  • Refractory B Acute Lymphoblastic Leukaemia

Interventions

BIOLOGICAL

CD19 CAR-T CELLS

CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.

DRUG

Cyclophosphamide

Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).

DRUG

Fludarabine

Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).

Sponsors & Collaborators

  • Gaia Science

    collaborator OTHER

  • National University of Malaysia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2027-01-18
Completion
2027-03-18

Countries

  • Malaysia

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 NCT03937544 on ClinicalTrials.gov