RecruitingPhase 2NCT06462248

Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies

A Single Arm, Open-labelled Phase II Clinical Trial of Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) for Treatment of B-cell Haematological Malignancies


Sponsor

Chi Kong Li

Enrollment

20 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

CAR-T therapy is now available as a commercial product for treatment of relapsed /refractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.


Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This trial offers CAR-T cell therapy targeting CD19 — a protein found on certain blood cancer cells — for people with relapsed or treatment-resistant B-cell blood cancers, including certain types of leukemia and lymphoma. The therapy uses your own immune cells, re-engineered to attack the cancer. **You may be eligible if...** - You have relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia (ALL), B-cell lymphoma, or CLL/SLL - For ALL: You are between 0 and 60 years old, in first or subsequent relapse, or have persistent measurable residual disease - You are in reasonably good functional health (ECOG ≤2 for adults, Lansky >50 for children) - Females of childbearing age must have a negative pregnancy test **You may NOT be eligible if...** - Your cancer does not express the CD19 protein - You have uncontrolled serious organ problems - You are pregnant or breastfeeding - You have active uncontrolled infections 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

DRUGCUCART19

anti-CD19 chimeric antigen receptor modified T-cell (CAR-T)


Locations(1)

Prince of Wales Hospital

Hong Kong, China

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NCT06462248


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