Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM

May 5, 2019 updated by: Asclepius Technology Company Group (Suzhou) Co., Ltd.
The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • Department of Hematology, Wuxi People's Hospital, Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years to 80 years, expected survival > 3 months
  2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry
  3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease
  4. ECOG performance status of 0 - 1
  5. Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN
  6. No serious allergic constitution
  7. No other serous diseases that conflicts with the clinical program
  8. No other cancer history
  9. Female participants of reproductive potential must have a negative serum pregnancy test
  10. Subjects must have signed written, informed consent

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive
  3. Active hepatitis B or hepatitis C infection
  4. Recent or current use of glucocorticoid or other immunosuppressor
  5. Serious mental disorder
  6. With severe cardiac, liver, renal insufficiency, diabetes and other diseases
  7. Participate in other clinical research in the past three months
  8. Previously treatment with any gene therapy products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anti-tumor response of BCMA CAR-NK-92
Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells.
Biological: BCMA CAR-NK 92 cells
The subject will be observed for any side effects during this time and all the adverse events will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
Time Frame: 1 year
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asclepius Technology Company Group (Suzhou) Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

May 5, 2019

First Submitted That Met QC Criteria

May 5, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 5, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AsclepiusTCG02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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