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הניסוי הקליני NCT07491263 עבור Relapsed/Refractory CD19-positive B-ALL הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia שלב I 6 תווית פתוחה
Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia
- QH10309-NHB-01(0)
CAR-γδT
cell therapy
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיPatients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells
Interventions:
Biological: QH103 Cell Injection Drug: Fludarabine Drug: Cyclophosphamide | Cyclophosphamide Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days). פלודרבין Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg/m² administered 3 days). QH103 Cell Injection Biological: CD19 CAR-γδT cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10\^8 CAR+cells) ,dose 2 (3× 10\^8 CAR+cells). |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Adverse Event | 12 months | |
Incidence of Dose-Limiting Toxicities (DLTs) | DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion. | 28 days |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
PK(Pharmacokinetics):Number and Copy Number of CD19 CAR-γδT cells | 12 months | |
PK: Persistence of CD19 CAR-γδT | 12 months | |
PD(Pharmacodynamics) :Changes in Various Cytokine Levels (IL-2, IL-4, IL-6, IFN-γ, TNF α, etc.) from Baseline | 12 months |
Age > 14 years, gender unrestricted;
Clinically diagnosed with relapsed/refractory acute B-lymphoblastic leukemia, with bone marrow blast/immature lymphocyte proportion ≥5% (morphology) (excluding cases with isolated extramedullary involvement), meeting any of the following criteria:
- Failure to achieve CR after 2 cycles of standard chemotherapy;
- Initial induction achieved CR, but CR duration ≤12 months;
- Relapsed/refractory B-ALL refractory to first or multiple salvage therapies;
- Post-hematopoietic stem cell transplantation relapse, including hematological relapse and minimal residual disease (MRD) positivity;
- Patients for whom no standard therapy exists.
Cytology or histology confirms tumor cell immunophenotype as CD19-positive;
Expected survival time exceeding 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
Key organ functions meeting the following criteria: left ventricular ejection fraction ≥50% by echocardiography; serum creatinine ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN; total bilirubin ≤1.5 × ULN;
Negative pregnancy test for women of childbearing potential; both males and females agree to use effective contraception during treatment and for 1 year thereafter;
- No significant hereditary diseases;
- Able to comprehend the trial requirements and procedures, and willing to participate in the clinical study as required;
- Signed informed consent form for the trial
Exclusion Criteria:
- Presence of central nervous system (CNS) involvement or a clinically significant history of CNS diseases, such as epilepsy and cerebrovascular diseases;
- Pregnant or lactating women, or women who disagree to use effective contraception during treatment and within 1 year after treatment;
- Other malignancies that are not in remission;
- Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
- Patients who have received allogeneic immune cell therapy within 6 months before enrollment, or donor lymphocyte infusion within 6 weeks before enrollment;
- Confirmed positive anti-FMC63 and DSA responses in the patient's serum;
- Patients who have participated in other clinical trials within 4 weeks before enrollment;
- Uncontrolled infectious diseases or other serious conditions, including but not limited to infections (human immunodeficiency virus, acute or chronic active hepatitis B or C), congestive heart failure, unstable angina, arrhythmia, or conditions considered by the treating physician to pose unpredictable risks;
- History of stroke or intracranial hemorrhage within 3 months before enrollment;
- Major surgery or trauma within 28 days before enrollment, or main side effects not yet recovered;
- History of allergy to any component of the cell product;
- Inability to understand or unwillingness to sign the informed consent form;
- Other reasons deemed by the researchers as unsuitable for the clinical trial.
Fujian