OncoMatch/Clinical Trials/NCT06326008
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
Is NCT06326008 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for b-cell acute lymphoblastic leukemia.
Treatment: Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (FCM >95%)
CD19+/CD22+ (FCM >95%) B-cell acute lymphoblastic leukaemia
Required: CD22 overexpression (FCM >95%)
CD19+/CD22+ (FCM >95%) B-cell acute lymphoblastic leukaemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunotherapy (Blinatumomab)
progressed despite or are intolerant to all standard therapies, including, but not limited to, immunotherapies such as Blinatumomab (BITE), Tyrosine kinase inhibitors (TKI), CAR T-cell therapy, etc.
Must have received: tyrosine kinase inhibitor
progressed despite or are intolerant to all standard therapies, including, but not limited to, immunotherapies such as Blinatumomab (BITE), Tyrosine kinase inhibitors (TKI), CAR T-cell therapy, etc.
Must have received: CAR-T cell therapy
progressed despite or are intolerant to all standard therapies, including, but not limited to, immunotherapies such as Blinatumomab (BITE), Tyrosine kinase inhibitors (TKI), CAR T-cell therapy, etc.
Cannot have received: hematopoietic stem cell transplant
Patients who have received previous haematopoietic stem cell transplantation (including peripheral blood haematopoietic stem cell transplantation and bone marrow haematopoietic stem cell transplantation)
Lab requirements
Kidney function
Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value [excluded]
Cardiac function
Symptomatic heart failure or severe cardiac arrhythmia [excluded]
Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value [excluded]; Symptomatic heart failure or severe cardiac arrhythmia [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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