RecruitingPhase 1NCT06326008

Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial

Safety, Tolerability and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allogeneic Haematopoietic Stem Cell Transplantation and Sequential Donor-derived CD22 CAR Therapy in Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia: a Clinical Trial

Sponsor

Beijing GoBroad Hospital

Enrollment

48 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia, in Relapse B-cell Acute Lymphoblastic Leukemia

Summary

This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\~12 cases in dose escalation phase and 36 cases in dose expansion phase.

Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment strategy for children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) — a blood cancer that has come back or stopped responding to treatment. The approach uses specialized immune cells called CAR T-cells (which are engineered from a donor, not the patient) to attack cancer cells, followed by a stem cell transplant from the same donor, and then another round of donor CAR T-cell therapy targeting a different marker. **You may be eligible if...** - You are between 1 and 18 years old - You have B-cell ALL that has relapsed or is resistant to all standard treatments including blinatumomab, TKIs, and CAR T-cell therapy - Your cancer cells express CD19 and CD22 markers - You have significant cancer in your blood or severe blood count problems - Your expected survival is at least 60 days - You are in reasonable health (ECOG score 0–2) **You may NOT be eligible if...** - You have adequate treatment options still available - You do not meet organ function requirements - You cannot provide suitable donor lymphocyte samples 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

DRUGDonor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy

Peripheral blood mononuclear cells for the production of CD19 CAR T cells and CD22 CAR T cells are collected from donors and haematopoietic stem cells are collected from donors.