Clincosm LogoSign in Get a demo

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

Sponsor
Affiliated Hospital to Academy of Military Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05645601
Collaborator
Beijing JD Biotech Co. LTD. (Other)
12
Enrollment
1
Location
1
Arm
25
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: CD19-CAR-NK
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Early Clinical Study of Allogenic CAR-NK Targeted CD19 (JD010) in the Treatment of Adult Relapsed or Refractory B-cell Malignancies
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CD19 CAR-NK(JD010)

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

Biological: CD19-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.

Outcome Measures

Primary Outcome Measures

  1. Dose limiting toxicities (DLTs) [1 Months]

  2. Treatment-related adverse events [3 months]

  3. Objective Response Rate (ORR) [3 months]

Secondary Outcome Measures

  1. Progression free survival (PFS) [12 months]

  2. Overall Survival (OS) [12 months]

  3. Proportion of subjects with minimal-residual disease (MRD) negative response [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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:

  1. 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%;

  1. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;

  2. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital Beijing Beijing China 100071

Sponsors and Collaborators

  • Affiliated Hospital to Academy of Military Medical Sciences
  • Beijing JD Biotech Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT05645601
Other Study ID Numbers:
  • CAR-NK-JD010
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 9, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms

Study Results

No Results Posted as of Dec 9, 2022