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

October 11, 2018 updated by: Peng Liu

Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • 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
      • Shanghai, China, 200032
        • Department of Hematology ,Fudan University Zhongshan Hospital

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:

  • 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

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-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.
Drug: Fludarabine
30mg/m2/d
Drug: Cyclophosphamide
300mg/m2/d
Biological: anti-CD19/BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time Frame: 6 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of CAR-positive T cells in circulation
Time Frame: 6 months
Duration of CAR-positive T cells in circulation
6 months
Overall remission rate defined by the standard response criteria for myeloma for each arm
Time Frame: 8 weeks
Overall remission rate defined by the standard response criteria for myeloma for each arm
8 weeks

Collaborators and Investigators

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

Sponsor

Peng Liu

Collaborators

Shanghai East Hospital
Hrain Biotechnology

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)

October 30, 2018

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (ACTUAL)

October 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHZS-MM002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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