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Trial record 3 of 526 for:    Neoplasms | Recruiting, Not yet recruiting, Available Studies | "Multiple Myeloma"

Study of BCMA CAR-T in Multiple Myeloma

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: NCT03322735
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : December 29, 2017
Sponsor:
Collaborator:
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Information provided by (Responsible Party):
Henan Cancer Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Fludarabine Drug: Cyclophosphamide Biological: BCMA CAR-T Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]
    number of participants with adverse events


Secondary Outcome Measures :
  1. Persistence of the BCMA CAR+ T cells [ Time Frame: 1 year ]
    determine duration of in vivo survival of BCMA CAR-T cells

  2. anti-tumor responses of BCMA CAR-T cells [ Time Frame: 1 year ]


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:

  • 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;

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): NCT03322735


Contacts
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Contact: Yongping Song +86-13521186987 ph200811@163.com

Locations
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China, Henan
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: Yongping Song    +86-13521186987    ph200811@163.com   
Principal Investigator: Yongping Song         
Sponsors and Collaborators
Henan Cancer Hospital
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Investigators
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Principal Investigator: Yongping Song Henan Cancer Hospital

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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03322735     History of Changes
Other Study ID Numbers: HenanCH284
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: October 2017

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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 phosphate
Fludarabine
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