RecruitingPhase 2NCT06081478

CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia

CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia: a Prospective, Single-arm, Single-center, Phase 2 Clinical Trial


Sponsor

Beijing Tongren Hospital

Enrollment

100 participants

Start Date

Jan 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2 clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.


Eligibility

Min Age: 14 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of cell therapy — called bispecific CAR-T cells — that targets two proteins (CD19 and CD22) on cancer cells in people with relapsed or treatment-resistant B-cell lymphoma or B-cell leukemia. This is an immune cell therapy where the patient's own immune cells are genetically modified to attack cancer. **You may be eligible if...** - You are between 14 and 85 years old - You have B-cell lymphoma or B-cell acute lymphoblastic leukemia (B-ALL) that has come back or stopped responding to standard treatment - Your cancer tests positive for CD19 and/or CD22 proteins - You have reasonable overall health (ECOG 0-2) - Your blood counts and organ function meet required minimums **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an uncontrolled infection, HIV, syphilis, or active hepatitis B or C - You are currently using steroids or immune-suppressing drugs - You have had previous gene therapy - You have severe heart, liver, or kidney disease - You have participated in another clinical trial in the past 3 months 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

DRUGCD19/CD22-bispecific CAR-T cells

CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively.


Locations(1)

Liang Wang

Beijing, Beijing Municipality, China

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NCT06081478


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