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

Primary Purpose

Adult Relapsed/Refractory B-cell Hematologic Malignancies

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19-CAR-NK
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Relapsed/Refractory B-cell Hematologic Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Central nervous system involved; Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide; Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids); 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. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; Women who are pregnant (urine/blood pregnancy test positive) or lactating; 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.

Sites / Locations

  • The Fifth Medical Center of Chinese People's Liberation Army (PLA) General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD19 CAR-NK(JD010)

Arm Description

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

Outcomes

Primary Outcome Measures

Dose limiting toxicities (DLTs)
Treatment-related adverse events
Objective Response Rate (ORR)

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2022
Last Updated
December 1, 2022
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Beijing JD Biotech Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05645601
Brief Title
CAR-NK Targeted CD19 for r/r B-cell Malignancies
Official Title
Early Clinical Study of Allogenic CAR-NK Targeted CD19 (JD010) in the Treatment of Adult Relapsed or Refractory B-cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Beijing JD Biotech Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Relapsed/Refractory B-cell Hematologic Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD19 CAR-NK(JD010)
Arm Type
Experimental
Arm Description
CD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.
Intervention Type
Biological
Intervention Name(s)
CD19-CAR-NK
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose limiting toxicities (DLTs)
Time Frame
1 Months
Title
Treatment-related adverse events
Time Frame
3 months
Title
Objective Response Rate (ORR)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
12 months
Title
Overall Survival (OS)
Time Frame
12 months
Title
Proportion of subjects with minimal-residual disease (MRD) negative response
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Central nervous system involved; Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide; Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids); 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. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; Women who are pregnant (urine/blood pregnancy test positive) or lactating; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liangding Hu, Dr
Phone
+86 01066947171
Email
huliangding@sohu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Sun, Dr
Phone
+86 01066947172
Email
suny320@126.com
Facility Information:
Facility Name
The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangding Hu, Ph.D
Phone
+86-010-6694-7171
Email
huliangding@sohu.com
First Name & Middle Initial & Last Name & Degree
Yao Sun, Ph.D
Phone
+86-010-6694-7172
Email
suny320@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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