NCT05645601

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

December 1, 2022

Last Update Submit

December 1, 2022

Conditions

Adult Relapsed/Refractory B-cell Hematologic Malignancies

Outcome Measures

Primary Outcomes (3)

  • Dose limiting toxicities (DLTs)

    1 Months

  • Treatment-related adverse events

    3 months

  • Objective Response Rate (ORR)

    3 months

Secondary Outcomes (3)

  • Progression free survival (PFS)

    12 months

  • Overall Survival (OS)

    12 months

  • Proportion of subjects with minimal-residual disease (MRD) negative response

    12 months

Study Arms (1)

CD19 CAR-NK(JD010)

EXPERIMENTAL

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

Biological: CD19-CAR-NK

Interventions

CD19-CAR-NKBIOLOGICAL

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.

CD19 CAR-NK(JD010)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Liangding Hu, Dr

CONTACT

+86 01066947171huliangding@sohu.com

Yao Sun, Dr

CONTACT

+86 01066947172suny320@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

December 1, 2022

Primary Completion

May 30, 2024

Study Completion

December 30, 2024

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)