RecruitingPhase 2Phase 3NCT03937544

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

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


Sponsor

National University of Malaysia

Enrollment

10 participants

Start Date

Mar 19, 2019

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 13 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy for adults and teenagers with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) — a type of blood cancer that has come back or stopped responding to standard treatment. CAR-T therapy uses your own immune cells, which are collected, genetically engineered to target cancer cells, and then infused back into your body. **You may be eligible if...** - You have B-cell ALL that has relapsed (come back) or is not responding to treatment - You are between 13 and 65 years old - You have no detectable leukemia in the fluid around your brain and spinal cord - Your organs are functioning well enough to tolerate the treatment **You may NOT be eligible if...** - You have active leukemia spreading to the central nervous system - You have serious active infections or other cancers - You have severe organ problems (heart, liver, kidney, lungs) - You are pregnant or breastfeeding - You have previously received CAR-T therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD19 CAR-T CELLS

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

DRUGCyclophosphamide

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

DRUGFludarabine

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


Locations(1)

UKM Medical Centre

Bandar Tun Razak, Kuala Lumpur, Malaysia

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NCT03937544