RecruitingPhase 1Phase 2NCT05948033

CD70 Targeted CAR-T Cells in CD70 Positive Relapsed/Refractory Lymphoma

Phase I/II Study of CD70 Targeted CAR-T Cell Treatment in CD70 Positive Relapsed/Refractory Lymphoma


Sponsor

Chinese PLA General Hospital

Enrollment

30 participants

Start Date

Jul 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive Relapsed/Refractory Lymphoma . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy that targets a protein called CD70 in people with relapsed or refractory lymphoma (lymphoma that has come back or stopped responding to treatment). CAR-T therapy involves modifying a patient's own immune cells to recognize and attack cancer cells. **You may be eligible if...** - You are between 18 and 75 years old with a confirmed diagnosis of lymphoma (including Hodgkin's lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, or other types) - Your lymphoma has relapsed after at least 2 prior treatments - Your cancer cells express the CD70 protein (at least 10% positive on testing) - Your overall health and organ function meet the required levels **You may NOT be eligible if...** - You are HIV-positive or have active hepatitis B or C - You have had a prior organ or stem cell transplant from a donor - You have cancer involving the brain - You have had another cancer within the past 5 years (except certain early-stage skin or cervical cancers) - You received recent cancer treatment or are on immune-suppressing medications 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

BIOLOGICALCD70-targeting CAR-T cells

Dose escalation: Dose1 (1×10\^6 cells/kg) ,Dose 2(3×10\^6 cells/kg) ,Dose 3 (1×10\^7 cells/kg) Doseexpansion: RP2D Drug: Fludarabine Intravenous fludarabine 25-30 mg/m\^2/day on days 5, -4, and -3. Drug: Cyclophosphamide Intravenous cyclophosphamide 300-500 mg/m\^2/day on days -5, -4, and -3.


Locations(1)

China

Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China

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NCT05948033


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