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a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04776330
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Chongqing Precision Biotech Co., Ltd

Brief Summary:
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Neoplasm, Plasma Cell Multiple Myeloma in Relapse Biological: BCMA targeted prime CAR-T cells Phase 1 Phase 2

Detailed Description:
There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: BCMA targeted prime CAR-T cells treat
Patients will be be treated with BCMA targeted prime CAR-T cells
Biological: BCMA targeted prime CAR-T cells
BCMA targeted prime CAR-T cell therapy




Primary Outcome Measures :
  1. Adverse events that related to treatment [ Time Frame: 2 years ]
    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

  2. The response rate of BCMA targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy [ Time Frame: 2 years ]
    The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG


Secondary Outcome Measures :
  1. Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood [ Time Frame: 2 years ]
    In vivo (bone marrow and peripheral blood) rate of BCMA targeted prime CAR-T cells were determined by means of flow cytometry

  2. Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood [ Time Frame: 2 years ]
    In vivo (bone marrow and peripheral blood) quantity of BCMA targeted prime CAR copies were determined by means of qPCR

  3. Quantity of clonal plasma cells in bone marrow [ Time Frame: 1 years ]
    In vivo (bone marrow) quantity of clonal plasma cells

  4. Levels of IL-6 in Serum [ Time Frame: 1years ]
    In vivo (Serum) quantity of IL-6

  5. Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [ Time Frame: 2 years ]
    DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored)

  6. Progress-free survival(PFS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [ Time Frame: 2 years ]
    PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)

  7. Overall survival(OS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [ Time Frame: 2 years ]
    OS will be assessed from the first prime CAR-T cell infusion to death from any cause (censored)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent;
  2. Diagnose as relapsed /refractory multiple myeloma, and meet one of the following conditions:

    1. Failed to standard chemotherapy regimens;
    2. Relapse after complete remission, high-risk and / or refractory patients ;
    3. Relapse after hematopoietic stem cell transplantation;
  3. Evidence for cell membrane BCMA expression
  4. All genders, ages: 18 to 75 years#
  5. The expect time of survive is above 3 months;
  6. KPS>60
  7. No serious mental disorders ;
  8. Left ventricular ejection fraction ≥50%
  9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
  11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;

13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

  1. Previous history of other malignancy;
  2. Presence of uncontrolled active infection;
  3. Evidence of disorder that need the treatment by glucocorticoids;
  4. Active or chronic GVHD
  5. The patients treatment by inhibitor of T cell
  6. Pregnant or breasting-feeding women;
  7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

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): NCT04776330


Contacts
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Contact: Zhi Yang, PhD 86-13206140093 yangzhi@precision-biotech.com

Locations
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China, Yunnan
920th Hospital of Joint Logistics Support Force Recruiting
Kunming, Yunnan, China
Contact: Sanbin Wang, MD       Sanbin1011@163.com   
Principal Investigator: Sanbin Wang, MD         
Sponsors and Collaborators
Chongqing Precision Biotech Co., Ltd
Investigators
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Principal Investigator: Sanbin Wang, MD 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Principal Investigator: Cheng Qian, PhD Chongqing University Cancer Hospital
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Responsible Party: Chongqing Precision Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT04776330    
Other Study ID Numbers: PBC027
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chongqing Precision Biotech Co., Ltd:
Multiple Myeloma
BCMA
prime Chimeric Antigen Receptor T Cell
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