RecruitingPhase 1NCT06445803

CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL

A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma


Sponsor

Rong Tao

Enrollment

48 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy that targets two proteins on cancer cells — CD19 and CD22 — in adults with relapsed or refractory B-cell leukemia (B-ALL) or B-cell lymphoma (B-NHL). CAR-T therapy involves engineering a patient's own immune cells to find and attack cancer cells. **You may be eligible if...** - You are 18 or older with confirmed B-cell leukemia or B-cell lymphoma that has returned or stopped responding to treatment - Your cancer has relapsed after multiple prior treatment lines, failed to respond, or relapsed after a stem cell transplant - You have good organ function and an ECOG performance status of 0–2 - Your estimated survival is at least 12 weeks **You may NOT be eligible if...** - You have received certain prior therapies such as bendamustine or fludarabine, or recent anti-T-cell antibodies - You have active or latent hepatitis B, active hepatitis C, or any uncontrolled infection - You have significant heart, liver, kidney, or brain conditions - You have an active autoimmune disease affecting major organs 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

BIOLOGICALKQ-2002 CAR-T cells (CD19/CD22 CAR T-Cells)

CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen. Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide. Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3)


Locations(2)

The First Affiliated Hospital of Nanchang University;

Nanchang, Jiangxi, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06445803


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