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A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed 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: NCT05712083
Recruitment Status : Recruiting
First Posted : February 3, 2023
Last Update Posted : February 21, 2023
Sponsor:
Collaborator:
Yake Biotechnology Ltd.
Information provided by (Responsible Party):
He Huang, Zhejiang University

Study Description
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Brief Summary:
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Condition or disease Intervention/treatment Phase
Multiple Myeloma New Diagnosis Tumor Drug: BCMA CAR-T cells Phase 2

Detailed Description:
This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Actual Study Start Date : January 30, 2023
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
This is a single arm clinical trial.
 Drug: BCMA CAR-T cells
Each subject receive BCMA CAR T-cells by intravenous infusion
Other Name: BCMA CAR-T cells injection


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) [ Time Frame: Baseline up to 28 days after BCMA CAR T-cells infusion ]
    Adverse events assessed according to NCI-CTCAE v5.0 criteria

  2. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline up to 2 years after BCMA CAR T-cells infusion ]
    Incidence of treatment-emergent adverse events [Safety and Tolerability]


Secondary Outcome Measures :
  1. Multiple Myeloma (MM), Overall response rate (ORR) [ Time Frame: At Month 1, 3, 6, 12, 18 and 24 ]
    Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24

  2. Complete response rate(CRR) [ Time Frame: Baseline up to 2 years after BCMA CAR T-cells infusion ]
    Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)

  3. Partial response Rate (PRR) [ Time Frame: Up to 2 years after BCMA CAR T-cells infusion ]
    Proportion of subjects who achieved a partial response (PR)

  4. Overall survival [ Time Frame: Up to 2 years after BCMA CAR T-cells infusion ]
    Death from any cause from the beginning of cell transfusion


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Age and gender unlimited;
  • 2.According to the IMWG2014 standard, diagnosis as multiple myeloma;
  • 3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
  • 4.Abnormal plasmocyte BCMA expression positive;
  • 5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
  • 6.The subject has no lung activity infection;
  • 7.Expected life time is more than 3 months;
  • 8.ECOG score 0-2 score;
  • 9.Voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

  • 1.Patients with the history of epilepsy or other CNS disease;
  • 2.Patients with prolonged QT interval time or severe heart disease;
  • 3.Pregnant or breastfeeding;
  • 4.Active infection with no cure;
  • 5.Patients with active hepatitis B or C infection;
  • 6.Previously treated with any genetic therapy;
  • 7.The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
  • 8.Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
  • 9.Those who suffer from other uncontrolled diseases are not suitable to join the study;
  • 10.HIV infection;
  • 11.Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Contacts and Locations
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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): NCT05712083


Contacts
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Contact: He Huang, MD 86-13605714822 hehuangyu@126.com
Contact: Mingming Zhang, MD 13656674208 mingmingzhang@zju.edu.cn

Locations
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China, Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: He Huang, MD    86-13605714822    hehuangyu@126.com   
Contact: Mingming Zhang, MD    13656674208    mingmingzhang@zju.edu.cn   
Sponsors and Collaborators
Zhejiang University
Yake Biotechnology Ltd.
Investigators
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Principal Investigator: He Huang, MD First Affiliated Hospital of Zhejiang University
More Information
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Responsible Party: He Huang, Clinical Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT05712083    
Other Study ID Numbers: IIT20210024C-R4
First Posted: February 3, 2023    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: January 2023

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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 He Huang, Zhejiang University:
BCMA CAR-T
Multiple Myeloma
New Diagnosis
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