RecruitingPhase 2NCT05648019

CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol


Sponsor

KK Women's and Children's Hospital

Enrollment

40 participants

Start Date

Mar 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.


Eligibility

Min Age: 0 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether CAR T-cell therapy — a treatment where a patient's own immune cells are engineered to attack cancer — is feasible and effective for people with B-cell leukemia or lymphoma that has come back or stopped responding to other treatments. **You may be eligible if...** - You have been diagnosed with relapsed or refractory B-cell leukemia (ALL) or B-cell lymphoma - Your cancer expresses CD19 (a protein found on cancer cells) - Standard treatments, including stem cell transplant, have not worked or are not an option - You are in adequate health to tolerate cell therapy **You may NOT be eligible if...** - You have active serious infections - You have significant organ dysfunction - You have received certain prior gene or cell therapies 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

BIOLOGICALAnti-CD19 CAR T-cells

A target per-protocol dose of vi able CD19 CAR transduced T-cells will consist of a single infusion of 0.2 to 5.0 x 10e6 lentiviral-transduced viable 41BB-CD19 CAR T-cells per kg body weight.


Locations(2)

Singapore General Hospital

Singapore, Singapore

KK Women's and Children's Hospital

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT05648019


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