Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM

NCT ID: NCT03706547

Last Updated: 2018-10-16

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

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2021-12-31

Brief Summary

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The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.

Detailed Description

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Primary Objectives

1\. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.

Secondary Objectives

1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.
2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.

Conditions

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Multiple Myeloma in Relapse Multiple Myeloma Progression

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-CD19/BCMA CAR-T cells

1. Chemotherapy with a classic combination with fludarabine and cyclophosphamide;
2. Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.

Group Type EXPERIMENTAL

anti-CD19/BCMA CAR-T cells

Intervention Type BIOLOGICAL

Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs

Fludarabine

Intervention Type DRUG

30mg/m2/d

Cyclophosphamide

Intervention Type DRUG

300mg/m2/d

Interventions

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anti-CD19/BCMA CAR-T cells

Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs

Intervention Type BIOLOGICAL

Fludarabine

30mg/m2/d

Intervention Type DRUG

Cyclophosphamide

300mg/m2/d

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Expected survival \> 12 weeks
* Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)
* Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma
* Exited measurable lesions and in accordance with one of the following test indicators: serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy
* The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days
* At least 90 days after stem cell transplantation
* Clinical performance status of ECOG score 0-2
* Creatinine≤2.0 mg/dl
* Bilirubin≤2.0 mg/dl
* The ALT/AST value is lower than 2.5-fold of normal value
* Accessible to intravenous injection, and no white blood cell collection contraindications
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom
* 5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion
* Able to understand and sign the Informed Consent Document.

Exclusion Criteria

* Patients with symptoms of central nervous system
* Patients with second malignancies in addition to multiple myeloma
* Active hepatitis B or C, HIV infections
* Any other active diseases could affect the enrollment of this trial
* Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
* Patients with organ failure
* Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
* A history of mental illness and poorly controlled
* Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
* Patients who are accounted by researchers to be not appropriate for this test
* Subjects suffering disease affects the understanding of informed consent or complying with study protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hrain Biotechnology

UNKNOWN

Sponsor Role collaborator

Shanghai East Hospital

OTHER

Sponsor Role collaborator

Peng Liu

OTHER

Sponsor Role lead

Responsible Party

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Peng Liu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Peng Liu, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

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Department of Hematology ,Fudan University Zhongshan Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Zheng Wei, M.D.

Role: CONTACT

+(86)-21 64041990 ext. 2925

References

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Other Identifiers

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SHZS-MM002

Identifier Type: -

Identifier Source: org_study_id

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