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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706547
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
Hrain Biotechnology
Shanghai East Hospital
Information provided by (Responsible Party):
Peng Liu, Shanghai Zhongshan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma in Relapse Multiple Myeloma Progression Biological: anti-CD19/BCMA CAR-T cells Drug: Fludarabine Drug: Cyclophosphamide Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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.
Biological: anti-CD19/BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs

Drug: Fludarabine
30mg/m2/d

Drug: Cyclophosphamide
300mg/m2/d




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Duration of CAR-positive T cells in circulation [ Time Frame: 6 months ]
    Duration of CAR-positive T cells in circulation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706547


Contacts
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Contact: Zheng Wei, M.D. +(86)-21 64041990 ext 2925 wei.zheng@zs-hospital.sh.cn

Locations
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China
Department of Hematology ,Fudan University Zhongshan Hospital Active, not recruiting
Shanghai, China, 200032
Sponsors and Collaborators
Peng Liu
Hrain Biotechnology
Shanghai East Hospital
Investigators
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Principal Investigator: Peng Liu, M.D. & Ph.D. Shanghai Zhongshan Hospital

Publications:

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Responsible Party: Peng Liu, Professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03706547     History of Changes
Other Study ID Numbers: SHZS-MM002
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites