Adult Relapsed/Refractory B-cell Hematologic Malignancies
Conditions
Brief summary
This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of JD010 in adult patients with relapsed or refractory B cell hematologic malignancies. JD010 injection is a CD19-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) derived from a healthy donor
Interventions
BIOLOGICALCD19-CAR-NK
The relapsed/refractory B-cell hematologic malignancies patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by 3 infusions of JD010 cells up to 2 dose levels (5x10\^6/kg, 2x10\^7/kg) after FC chemotherapy.
Sponsors
Beijing JD Biotech Co. LTD.
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old, no gender or race; 2. Expected survival period ≥ 3 months; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; 4. Confirmed relapsed/refractory B-cell malignancies and tumor cells expressing CD19; 5. Adequate organ function: A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; 6. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; 7. Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
1. Central nervous system involved; 2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide; 3. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids); 4. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis. 5. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; 6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; 7. Women who are pregnant (urine/blood pregnancy test positive) or lactating; 8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness; 10\. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicities (DLTs) | 1 Months |
| Treatment-related adverse events | 3 months |
| Objective Response Rate (ORR) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | 12 months |
| Overall Survival (OS) | 12 months |
| Proportion of subjects with minimal-residual disease (MRD) negative response | 12 months |
Countries
China
Contacts
Primary ContactLiangding Hu, Dr
Backup ContactYao Sun, Dr
Outcome results
None listed