RecruitingPhase 1Phase 2NCT06838832

Novel Allogenic CD19-targeting CAR-γδT Cell Therapy (QH103E) in r/r NHL

Novel Allogenic CD19-targeting Chimeric Antigen Receptor γδT Cells Therapy (QH103E) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma


Sponsor

Chinese PLA General Hospital

Enrollment

30 participants

Start Date

Jul 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

CD19-CAR-γδT cell therapy is a cellular immunotherapy targeting CD19 to perform CAR modification on allogeneic γδT cells. A novel version of the CAR-γδT product by gene editing (QH103E) that has been validated for resistance to alloreactive T cell killing and enhancement of memory efficacy will be used in this study. This is a single center, prospective, open-label, single-arm, phase 1/2 study. A total of around 30 patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) will be enrolled in the study and receive QH103E product infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of QH103E in patients with r/r B-cell NHL.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy (called CAR-T cell therapy, using donor gamma-delta T cells) for people with a blood cancer called B-cell non-Hodgkin lymphoma (NHL) that has come back or stopped responding to other treatments. The therapy genetically modifies immune cells to attack cancer cells with a protein called CD19. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with CD19-positive B-cell NHL confirmed by a lab test - Your cancer has relapsed or stopped responding after at least 2 previous treatments - You have adequate organ function and general health **You may NOT be eligible if...** - You have active, untreated brain involvement from your cancer - You have serious infections or uncontrolled other diseases - You have received certain prior stem cell transplants or CAR-T therapies that would disqualify you - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAllogenic CD19-CAR-γδT cell

Phase 1 dose escalation (3+3) : dose 1 (1 × 10\^6 cells/kg) , dose 2 (3 × 10\^6 cells/kg), dose 3 (6× 10\^6 cells/kg); Phase 2 : dose of RP2D.

DRUGFludarabine

Intravenous fludarabine 30\~50 mg/m\^2/day on days -5, -4, and -3.

DRUGCyclophosphamide

Intravenous cyclophosphamide 500\~1000 mg/m\^2/ day on days -5, -4, and -3.


Locations(1)

Biotherapeutic Department of Chinsese PLA Gereral Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06838832


Related Trials