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BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03664661
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Information provided by (Responsible Party):
Henan Cancer Hospital

Brief Summary:
Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Myeloma Drug: BCMA nanobody CAR-T cells Phase 1

Detailed Description:
There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : April 10, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: experimental group
BCMA nanobody CAR-T cells
Drug: BCMA nanobody CAR-T cells

step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients.

After finishing this, another 6 patients will be enrolled for observation of efficacy.





Primary Outcome Measures :
  1. occurrence of study related adverse events [ Time Frame: 4 weeks ]
    safety of CAR-T cells


Secondary Outcome Measures :
  1. Treatment response rate [ Time Frame: 3 months and 6 months ]
    response rate according to IMWG criteria

  2. copy number of CAR-T cells [ Time Frame: one year ]
    copy number of CAR-T cells



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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:

  • 18 and ≤70 years old and the expected lifetime >3 months

    • Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
    • No effective treatment option available
    • ECOG score 0-2
    • Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
    • smoothly peripheral superficial veins
    • No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
    • No history of other malignancies
    • Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
    • The patient himself agrees to participate in this clinical study and signed the "informed consent"

Exclusion Criteria:

  • Severe infectious 4 weeks before enrollment
  • Active hepatitis B or C viral hepatitis, HIV,
  • Severe autoimmune disease or immunodeficiency disease
  • Severe allergies
  • Severe mental disorder
  • Patients who used high-dose glucocorticoids within 1 week
  • Participation in other clinical studies in the past 3 months or having been treated with other gene 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): NCT03664661


Contacts
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Contact: Yongping Song, M.D +86-371-65587199 songyongping2018@126.com
Contact: Quanli Gao, M.D +86-15038171966 gaoquanli2015@126.com

Locations
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China, Henan
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450000
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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Study Chair: Yongping Song, M.D Henan Cancer Hospital

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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03664661     History of Changes
Other Study ID Numbers: HenanCH CAR 2-2
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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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