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| Name | Class |
|---|---|
| Beijing JD Biotech Co. LTD. | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19 CAR-NK(JD010) | Experimental | CD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-CAR-NK | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities (DLTs) | 1 Months | |
| Treatment-related adverse events | 3 months | |
| Objective Response Rate (ORR) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | 12 months | |
| Overall Survival (OS) | 12 months | |
| Proportion of subjects with minimal-residual disease (MRD) negative response |
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Inclusion criteria:
Age ≥ 18 years old, no gender or race;
Expected survival period ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
Confirmed relapsed/refractory B-cell malignancies and tumor cells expressing CD19;
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%;
Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;
Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
10. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangding Hu, Dr | Contact | +86 01066947171 | huliangding@sohu.com | |
| Yao Sun, Dr | Contact | +86 01066947172 | suny320@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12 months |