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

Phase 1

Recruiting

• Conditions: Adult Relapsed/Refractory B-cell Hematologic Malignancies
• Interventions: Biological: CD19-CAR-NK

• Registration Number: NCT05645601
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-01
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Last Update Submitted: 2022-12-01
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09
• Primary Completion: 2024-05-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19 CAR-NK(JD010)	CD19-CAR-NK	CD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	3 months
Dose limiting toxicities (DLTs)	1 Months
Treatment-related adverse events	3 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	12 months
Proportion of subjects with minimal-residual disease (MRD) negative response	12 months
Progression free survival (PFS)	12 months

Trial Locations

Locations (1)

The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital; 🇨🇳 Beijing, Beijing, China