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CAR-T Cells in Treating Patients With Relapsed or Refractory 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: NCT04626752
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Study Description
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Brief Summary:
This study is aimed to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: BCMA CAR-T Drug: Fludarabine Drug: Cyclophosphamide Early Phase 1

Detailed Description:

This is a study to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma.

The Main research objectives:

To evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.

The Secondary research objectives:

To evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Multiple Myeloma (MM)
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

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: volunteers
The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) Multiple Myeloma (MM)
 Drug: BCMA CAR-T
Volunteers will be treated with BCMA CAR-T cells
Other Name: senl_BCMA

Drug: Fludarabine
25mg/㎡ for D-4、D-3 and D-2
Other Name: flu

Drug: Cyclophosphamide
500mg/㎡ for D-3 and D-2
Other Name: ctx


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Severe/Adverse Events as a Measure of Safety [ Time Frame: 28 days ]
    Number of Participants with Severe/Adverse Events as a Measure of Safety

  2. CAR-T Cell expansion level [ Time Frame: 24 months ]
    Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)


Secondary Outcome Measures :
  1. Objective response rate of complete remission and partial remission [ Time Frame: 24 months ]
    Objective response rate of complete remission and partial remission

  2. Overall survival time [ Time Frame: 24 months ]
    Overall survival time


Eligibility Criteria
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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. The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian;
  2. According to the international standard for multiple myeloma (IMWG 2014);

  3. Diagnosed as relapsed or refractory multiple myeloma. Relapsed and refractory were defined as follow.

    Relapsed: patients had received for at least 3 drugs with different mechanisms of action (including protease inhibitors and immunomodulators) and disease progression within 60 days of the most recent treatment. Refractory was defined as: disease progression occurred during the recent treatment, or disease progression occurred within 60 days after treatment;

  4. The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry;
  5. No antibody drug was administered within last 2 weeks before cell therapy;
  6. ECOG Scores: 0~1
  7. Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥ 50%, no serious arrhythmia;
  8. The subjects had no pulmonary infection, normal pulmonary function, and indoor air oxygen saturation ≥92%;
  9. There was no contraindication for peripheral blood sampling;
  10. The estimated survival time was more than 12 weeks;
  11. The urine pregnancy test of female subjects of childbearing age should be negative and not in lactation; the female or male subjects of childbearing age should take effective contraceptive measures during the whole research process.

Exclusion Criteria:

  1. Have a history of allergy to any component of cell products;
  2. There are clinically significant cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade 3 (moderate) or grade 4 (severe) heart disease with cardiac function (according to the functional classification method of the New York Heart AssociationNYHA) with a history of myocardial infarction, angioplasty or stent implantation, unstable angina or other clinically significant heart disease within 12 months before admission;
  3. who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
  4. Patients who need urgent treatment due to tumor progression or spinal cord compression;
  5. The investigator determines that there are serious complications or diseases that will increase the risk of the subject or affect the study, including but not limited to, for example, cirrhosis, recent major trauma, etc;
  6. After allogeneic hematopoietic stem cell transplantation;
  7. Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive（excluding glucocorticoid）therapy;
  8. There was uncontrolled active infection;
  9. There were live vaccinations within 4 weeks before admission;
  10. Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection;
  11. Subjects had a history of alcohol, drug or mental illness;
  12. The researchers believe that there are other conditions that subjects are not suitable to participate in this study.
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): NCT04626752


Contacts
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Contact: Jianqiang Li, PhD&MD +8631189928689 limmune@gmail.com
Contact: Jianmin Luo, PhD&MD +8631166002304

Locations
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China, Hebei
the Second Hospital of HeBei Medical University (HBMU) Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Jianqiang Li, MD    86-311-82970975    hr@senlangbio.com   
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Investigators
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Principal Investigator: Jianmin Luo, PhD&MD The Second Hospital of Hebei Medical University
More Information
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04626752    
Other Study ID Numbers: CAR-T for Multiple myeloma
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists