Study of BCMA CAR-T in Multiple Myeloma

December 28, 2017 updated by: Henan Cancer Hospital

A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma

The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition 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)

10

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 Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yongping Song

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. 18 years to 70 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 0-2;
  • 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，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; 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: anti-tumor response of BCMA CAR-T

Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days.

Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.
Drug: Fludarabine
25-30mg/m2/day IV for 3 days
Drug: Cyclophosphamide
cyclophosphamide 0.6-0.8g/m2/day IV for 2 days
Biological: BCMA CAR-T
BCMA CAR-T cells will be administered after completion of the chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 1 year
number of participants with adverse events
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of the BCMA CAR+ T cells
Time Frame: 1 year
determine duration of in vivo survival of BCMA CAR-T cells
1 year
anti-tumor responses of BCMA CAR-T cells
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Henan Cancer Hospital

Collaborators

The Pregene (ShenZhen) Biotechnology Company, Ltd.

Investigators

  • Principal Investigator: Yongping Song, Henan Cancer Hospital

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 (ACTUAL)

December 8, 2017

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (ACTUAL)

October 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanCH284

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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