Actively Recruiting
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
Led by Beijing GoBroad Hospital · Updated on 2026-03-09
48
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory CD19+/CD22+ B-cell acute lymphoblastic leukemia with progression despite or intolerance to standard therapies
- Peripheral blood tumor burden ≥60% or severe peripheral blood cytopenia making autologous lymphocyte collection unsuitable
- Age between 1 and 18 years
- Expected survival time of at least 60 days
- Physical status with an ECOG score of 0 to 2
- Availability of an allogeneic donor (HLA-identical or HLA-haploidentical) who is DSA-negative for cell collection
- Signed informed consent form by patient or legal guardian as appropriate based on age
You will not qualify if you...
- Previous hematopoietic stem cell transplantation
- Intracranial hypertension or impaired consciousness
- Symptomatic heart failure or severe cardiac arrhythmia
- Severe respiratory failure symptoms
- Presence of other malignant tumors
- Diffuse intravascular coagulation
- Elevated serum creatinine and/or urea nitrogen ≥1.5 times normal
- Sepsis or other uncontrollable infections
- Uncontrollable diabetes mellitus
- Severe mental disorders
- Significant intracranial lesions on MRI (excluding CNS leukemia masses)
- History of organ transplant
- Female patients of childbearing potential with positive blood HCG test
- Hepatitis B or C, AIDS, or syphilis positive screening
- No suitable allogeneic donor available for cell collection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
Research Team
T
Tengyu Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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