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Anti-CD19 Universal CAR-NK Cells Therapy Combined With HSCT for B Cell Hematologic Malignancies

Sponsor
Kunming Hope of Health Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05570188
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
37
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 U-CAR-NK Cells Therapy combined with HSCT for B cell hematologic malignancies.

Condition or Disease Intervention/Treatment Phase
  • Biological: anti-CD19 UCAR-NK cells
 Phase 1/Phase 2

Detailed Description

Who can participate? Patients who were diagnosed with B cell hematologic malignancies and tumor cells expressing CD19.

How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-CD19 U-CAR-NK cells, which belong to chimeric antigen receptor modified NK cells. The administration time is 1-7 days after hematopoietic stem cell infusion. Patients were then evaluated for long-term efficacy and safety until 2 years after U-CAR-NK cells infusion.

What are the possible benefits and risks of participating? Benefits: The Dual effect of anti-tumor and anti-infection of NK cells may be used to promote the engraftment of hematopoietic stem cell and better disease control.

Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, thrombocytopenia, thrombotic microangiopathy, and possibly other unknown adverse reactions.

Where is the study run? Kunming Hope of Health Hospital.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-CD19 Universal CAR-NK(U-CAR-NK) Cells Therapy Combined With Hematopoietic Stem Cell Transplantation(HSCT) for B Cell Hematologic Malignancies
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Patients will get infused with anti-CD19 CAR-NK cells within 1 week after hematopoietic stem cell infusion.

Biological: anti-CD19 UCAR-NK cells
Enrolled participants are chosen to receive one of three different dose levels of U-CAR-NK cells: Dose level one: 5-10×10^6/kg; Dose level two:1-2×10^7/kg; Dose level three:2-5×10^7/kg.

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events(AE) after infusion [Up to 12 months after infusion]

    The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.

Secondary Outcome Measures

  1. Granulocyte implantation time [Up to 1 month after infusion]

    Time from hematopoietic stem cell transfusion to peripheral blood granulocyte count >0.5×10^9/L for 3 consecutive days.

  2. Platelet implantation time [Up to 1 month after infusion]

    Time from hematopoietic stem cell transfusion to peripheral blood platelet count >20×10^9/L for 7 consecutive days.

  3. Red blood cell implantation time [Up to 1 month after infusion]

    Time from hematopoietic stem cell transfusion to peripheral blood hemoglobin count >70g/L.

  4. Duration of remission (DOR) [Up to 24 weeks after infusion]

    Duration of remission (DOR) refers to the time from the first assessment of CR or PR of the tumor to the first assessment of disease recurrence or progression or death from any cause.

  5. Disease control rate (DCR) [Up to 24 weeks after infusion]

    Disease control rate (DCR) are defined as the percentage of patients who have achieved complete response, partial response or stable disease to a therapeutic intervention in clinical trials of anticancer agents.

  6. Overall survival (OS) [Up to 24 weeks after infusion]

    Overall survival (OS) refers to the time from the time the patient received an infusion of CAR-NK cells until death (from any cause).

  7. Progression-free survival (PFS) [Up to 24 weeks after infusion]

    Progression-free survival (PFS) refers to the time from the start of treatment with CAR-NK cells to the first progression of disease or death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Patients with indications for hematopoietic stem cell transplantation;

  2. Age ≤75 years old;

  3. Confirmed B-cell tumor and tumor cells expressing CD19；

  4. Expected survival time >12 weeks;

  5. ECOG score is 0-2;

  6. Adequate liver , kidney and cardiopulmonary function;

  7. Willingness to complete the informed consent process and to comply with study procedures and visit schedule.

Exclusion Criteria:

  1. Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening;

  2. At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening;

  3. Patients who had undergone hematopoietic stem cell transplantation (ASCT), allogeneic hematopoietic stem cell transplantation (HSCT), or solid organ transplantation within 12 weeks before screening; Grade 2 or higher GVHD requiring immunosuppressive therapy occurred within 2 weeks before screening;

  4. Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;

  5. Have received live attenuated vaccine within 6 weeks before rinsing;

  6. Had a cerebrovascular accident or seizure within 6 months before screening;

  7. History of deep venous thrombosis or pulmonary embolism within 6 months before screening;

  8. A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening;

  9. Previous history of Alzheimer's disease;

  10. Autoimmune diseases leading to end-organ damage or requiring systemic immunosuppression (e.g. Crohns, rheumatoid arthritis, systemic lupus erythematosus) within 2 years prior to screening;

  11. There are uncontrollable infections;

  12. Women who are pregnant or breastfeeding; Or women of childbearing age who have positive pregnancy tests during the screening period; Male or female patients who did not wish to use contraception from the time of signing the informed consent to 1 year after receiving the NK cell infusion;

  13. Conditions that other researchers deemed inappropriate for participating in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kunming Hope of Health Hospital Kunming Yunnan China 650000

Sponsors and Collaborators

  • Kunming Hope of Health Hospital

Investigators

  • Principal Investigator: Li Li, MD, Kunming Hope of Health Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kunming Hope of Health Hospital
ClinicalTrials.gov Identifier:
NCT05570188
Other Study ID Numbers:
  • PBC042
First Posted:
Oct 6, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kunming Hope of Health Hospital
universal CAR-NK
Hematopoietic Stem Cell Transplantation(HSCT)
Additional relevant MeSH terms:
Hematologic Neoplasms
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Nov 30, 2022