RecruitingPhase 1Phase 2NCT06880913

Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL

A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia


Sponsor

Peking University People's Hospital

Enrollment

50 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL


Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new CAR-T cell therapy that targets two proteins — CD19 and CD22 — found on B-cell leukemia cells. It uses nanobody-based technology (very small, precise targeting molecules) to attack cancer cells. The therapy is for people with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) — a blood cancer that has returned or stopped responding to treatment. **You may be eligible if:** - You are between 3 and 65 years old - You have been diagnosed with B-ALL that has relapsed or is refractory (not responding to treatment) - Your cancer has been confirmed to have more than 5% blast cells in bone marrow, leukemic cells in spinal fluid, or measurable tumors outside the bone marrow - You have an expected survival of at least 12 weeks and are in good general health **You may NOT be eligible if:** - You are under 3 or over 65 years old - You do not have B-ALL (e.g., you have T-cell ALL) - Your cancer does not meet the relapsed/refractory criteria - You have serious organ dysfunction or active uncontrolled infection - You are pregnant 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

BIOLOGICALNanobody-Based CD19/CD22 Tandem Dual CAR-T

Phase I: Patients will receive a single infusion of autologous CD19/CD22 dual CAR-T cells at one of three dose levels (0.3 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine (25-30mg/m2\*3d) and cyclophosphamide (250-300mg/m2\*3d) (FC) lymphodepleting chemotherapy. Phase II: Patients will receive autologous CD19/CD22 dual CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.


Locations(1)

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06880913