Relapsed/Refractory CD19-positive B-ALL
Conditions
Keywords
CD19, CAR-γδT, cell therapy
Brief summary
This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.
Interventions
DRUGCyclophosphamide
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).
DRUGFludarabine
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).
BIOLOGICALQH103 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).
Sponsors
Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. Failure to achieve CR after 2 cycles of standard chemotherapy; 2. Initial induction achieved CR, but CR duration ≤12 months; 3. Relapsed/refractory B-ALL refractory to first or multiple salvage therapies; 4. Post-hematopoietic stem cell transplantation relapse, including hematological relapse and minimal residual disease (MRD) positivity; 5. 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; * Toxicity from prior anti-tumor therapy ≤ Grade 1 (according to CTCAE v5.0) or at an acceptable level per inclusion/
Exclusion criteria
; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | 12 months | — |
| Incidence of Dose-Limiting Toxicities (DLTs) | 28 days | DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTTing Yang
Outcome results
None listed