RecruitingEarly Phase 1NCT06446128

A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)

A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)


Sponsor

Shanghai Cell Therapy Group Co.,Ltd

Enrollment

20 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a triple-target CAR-T cell therapy — which is engineered to attack three proteins on cancer cells (CD19, CD22, and BCMA) simultaneously — in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (a type of blood cancer) that has stopped responding to standard treatment. **You may be eligible if...** - You have confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (including DLBCL, PMBCL, transformed follicular lymphoma, or high-grade B-cell lymphoma) - Your cancer did not respond to or relapsed after standard treatments including anti-CD20 therapy and chemotherapy - At least two of the three target proteins (CD19, CD22, BCMA) are present on your cancer cells - You are in good health (ECOG 0–1) with a life expectancy of at least 12 weeks - Your heart, kidney, and liver function are within acceptable ranges **You may NOT be eligible if...** - You have received certain prior therapies that could interfere - You have active, uncontrolled infections or severe organ dysfunction - You have recently had a stem cell transplant 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/CD20/BCMA CAR T cells

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CD19/CD20/BCMA CAR T cells. Cyclophosphamide and fludarabine will be given from day-5 to day-3 before the infusion for lymphodepletion. On day0 subjects will receive one dose treatment with CD19/CD20/BCMA CAR T cells by intravenous (IV) injection


Locations(1)

Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT06446128


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