CAR-NK Targeted CD19 for r/r B-cell Malignancies

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Enrolling; Phase 1

Conditions: Adult Relapsed/Refractory B-cell Hematologic Malignancies

Treatments: Biological: CD19-CAR-NK

Study type: Interventional

Funder types: Other

Identifiers

NCT05645601

CAR-NK-JD010

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

9. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

CD19 CAR-NK(JD010)

Experimental group

Description:

CD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.

Treatment:

Biological: CD19-CAR-NK