Clinical trial · Interventional
CAR-NK Targeted CD19 for r/r B-cell Malignancies
Early Clinical Study of Allogenic CAR-NK Targeted CD19 (JD010) in the Treatment of Adult Relapsed or Refractory B-cell Malignancies
NCT05645601CI-TRIAL-00062602unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Relapsed/Refractory B-cell Hematologic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-CAR-NK | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19 CAR-NK(JD010)
- description
- CD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.
- interventionNames
- Biological: CD19-CAR-NK
Primary outcomes (3)
- measure
- Dose limiting toxicities (DLTs)
- timeFrame
- 1 Months
- measure
- Treatment-related adverse events
- timeFrame
- 3 months
- measure
- Objective Response Rate (ORR)
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.