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Study of BCMA CAR-T in Multiple Myeloma

NCT ID: NCT03322735

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-08

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

25-30mg/m2/day IV for 3 days

Cyclophosphamide

Intervention Type DRUG

cyclophosphamide 0.6-0.8g/m2/day IV for 2 days

BCMA CAR-T

Intervention Type BIOLOGICAL

BCMA CAR-T cells will be administered after completion of the chemotherapy.

Interventions

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Fludarabine

25-30mg/m2/day IV for 3 days

Intervention Type DRUG

Cyclophosphamide

cyclophosphamide 0.6-0.8g/m2/day IV for 2 days

Intervention Type DRUG

BCMA CAR-T

BCMA CAR-T cells will be administered after completion of the chemotherapy.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Pregene (ShenZhen) Biotechnology Company, Ltd.

INDUSTRY

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongping Song

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

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Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongping Song

Role: CONTACT

Phone: +86-13521186987

Email: [email protected]

Facility Contacts

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Yongping Song

Role: primary

Other Identifiers

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HenanCH284

Identifier Type: -

Identifier Source: org_study_id