RecruitingPhase 1Phase 2NCT06874946

Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/LBL

A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD5-Targeted CAR-T Cells for the Treatment of Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL) - The CONQUER Trial


Sponsor

Peking University People's Hospital

Enrollment

30 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL/LBL.


Eligibility

Min Age: 3 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy — a treatment where your own immune cells are engineered to attack cancer — for people with a hard-to-treat blood cancer called T-cell leukemia or lymphoma that has come back or stopped responding to treatment. **You may be eligible if...** - You are between 3 and 70 years old - You have been diagnosed with relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma - You are in reasonably good physical condition (ECOG 0-2) - You are expected to live at least 12 weeks **You may NOT be eligible if...** - You have severe organ problems (heart, liver, kidney, or lung) - You have an active, uncontrolled infection - You are pregnant or breastfeeding - You have received certain prior CAR-T therapies 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

BIOLOGICALCD5-targeted CAR-T cells

Phase I: Eligible patients will receive a single infusion of CD5-targeted CAR-T cells at one of three dose levels (0.5 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine and cyclophosphamide (FC) lymphodepleting chemotherapy. A 3+3 dose-escalation design will be used to determine the recommended Phase II dose (RP2D) based on safety, dose-limiting toxicities (DLTs), and preliminary efficacy. Phase II: Patients will receive CD5-targeted CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06874946