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

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

Study Overview

• Status: Unknown
• Conditions: Multiple Myeloma
• Intervention / Treatment: Biological: BCMA CAR-T

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Yanda, Hebei, China
      • Recruiting
      • He bei Yan da Lu dao pei Hospital
      • Contact: Peihua Lu, MD/PhD
  • Yizhuang
    • Beijing, Yizhuang, China, 100000
      • Recruiting
      • BeiJing Ludaopei Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Incidence and severity of adverse events	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	First month post CAR-T cells infusion
Efficacy: Overall Remission Rate (ORR)	Overall Remission Rate (ORR) including partial remission and complete	3 months post CAR-T cells infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy:duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion
Cytokine release	Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method	First month post CAR-T cells infusion
CAR-T proliferation	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	3 months post CAR-T cells infusion

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Collaborators: Hebei Yanda Ludaopei Hospital; Beijing Lu Daopei Hospital
• Investigators: Principal Investigator: Peihua Lu, PhD&MD, Beijing Lu Daopei Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2020
• Primary Completion (ANTICIPATED): August 30, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (ACTUAL): June 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: BCMA，MM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: BCMA CAR-T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No