Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT04447573
• Recruitment Status: Unknown
• First Posted: June 25, 2020
• Last Update Posted: September 29, 2020
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Collaborators: Beijing Lu Daopei Hospital; Hebei Yanda Ludaopei Hospital
• Information provided by (Responsible Party): Hebei Senlang Biotechnology Inc., Ltd.

Study Description

Brief Summary:

This study is aimed to evaluate the safety, feasibility and efficacy of BCMA CAR-T in the treatment of relapsed or refractory multiple myeloma

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Biological: BCMA CAR-T	Not Applicable

Detailed Description:

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

The Main research objectives:

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

The Secondary research objectives:

To investigate the cytokinetic characteristics of BCMA CAR-T in patients with relapsed or refractory multiple myeloma.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma
• Actual Study Start Date: June 30, 2020
• Estimated Primary Completion Date: August 30, 2022
• Estimated Study Completion Date: December 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: BCMA CAR-T cells; Patients will be treated with BCMA CAR-T cells	Biological: BCMA CAR-T; Biological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

Outcome Measures

Primary Outcome Measures :

1. Safety: Incidence and severity of adverse events [ Time Frame: First month post CAR-T cells infusion ]
   To evaluate the possible adverse events occurred within first one month after BCMA CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
2. Efficacy: Overall Remission Rate (ORR) [ Time Frame: 3 months post CAR-T cells infusion ]
   Overall Remission Rate (ORR) including partial remission and complete

Secondary Outcome Measures :

1. Efficacy:duration of response (DOR) [ Time Frame: 24 months post CAR-T cells infusion ]
   duration of response (DOR)
2. Efficacy: progression-free survival (PFS) [ Time Frame: 24 months post CAR-T cells infusion ]
   progression-free survival (PFS) time
3. CAR-T proliferation [ Time Frame: 3 months post CAR-T cells infusion ]
   the copy number of BCMA CAR- T cells in the genomes of PBMC by qPCR method and percentage of BCMA CAR- T cells measured by flow cytometry method
4. Cytokine release [ Time Frame: First month post CAR-T cells infusion ]
   Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Eligibility Criteria

• 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. 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

Contacts

Contact: Peihua Lu, PhD&MD; 008618611636172; peihua_lu@126.com

Contact: Jianqiang Li, PhD&MD; 008615511369555; limmune@gmail.com

Locations

China, Hebei

He bei Yan da Lu dao pei Hospital; Recruiting

Yanda, Hebei, China

Contact: Peihua Lu, MD/PhD

China, Yizhuang

BeiJing Ludaopei Hospital; Recruiting

Beijing, Yizhuang, China, 100000

Contact: Peihua Lu, PhD&MD 008618611636172 peihua_lu@126.com

Principal Investigator: Peihua Lu, PhD&MD

Sub-Investigator: Jianqiang Li, PhD&MD

Sponsors and Collaborators

Hebei Senlang Biotechnology Inc., Ltd.

Beijing Lu Daopei Hospital

Hebei Yanda Ludaopei Hospital

Investigators

• Principal Investigator: Peihua Lu, PhD&MD; Beijing Lu Daopei Hospital

More Information

• Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
• ClinicalTrials.gov Identifier: NCT04447573
• Other Study ID Numbers: BCMA CAR-T
• First Posted: June 25, 2020
• Last Update Posted: September 29, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hebei Senlang Biotechnology Inc., Ltd.:

BCMA，MM

Additional relevant MeSH terms:

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