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

NCT04447573 | Unknown

• 1 other identifier: BCMA CAR-T
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Multiple Myeloma

Keywords

BCMA，MM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Efficacy:duration of response (DOR)

  24 months post CAR-T cells infusion

• Efficacy: progression-free survival (PFS)

  24 months post CAR-T cells infusion

• CAR-T proliferation

  3 months post CAR-T cells infusion

• Cytokine release

  First month post CAR-T cells infusion

Study Arms (1)

BCMA CAR-T cells

EXPERIMENTAL

Patients will be treated with BCMA CAR-T cells

Biological: BCMA CAR-T

Interventions

BCMA CAR-T BIOLOGICAL

Biological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

BCMA CAR-T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily participated in the study and signed the informed consent form by themselves or their legal guardian;
• According to the international standard for multiple myeloma (IMWG 2014);
• 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;
• The expression of BCMA in myeloma cells was reported as positive by flow cytometry or immunohistochemistry;
• No antibody drug was administered within last 2 weeks before cell therapy;
• ECOG Scores: 0\~1
• Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥ 50%, no serious arrhythmia;
• The subjects had no pulmonary infection, normal pulmonary function, and indoor air oxygen saturation ≥ 92%;
• There was no contraindication for peripheral blood sampling;
• The estimated survival time was more than 12 weeks;
• 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.

You may not qualify if:

• Have a history of allergy to any component of cell products;
• 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;
• who has suffered from brain injury, consciousness disorder, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
• Patients who need urgent treatment due to tumor progression or spinal cord compression;
• 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;
• After allogeneic hematopoietic stem cell transplantation;
• Patients with autoimmune diseases, immunodeficiency or other diseases requiring immunosuppressive （excluding glucocorticoid）therapy;
• There was uncontrolled active infection;
• There were live vaccinations within 4 weeks before admission;
• Active hepatitis (positive for HBVDNA or HCVRNA), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to those with HIV infection;
• Subjects had a history of alcohol, drug or mental illness;
• The researchers believe that there are other conditions that subjects are not suitable to participate in this study.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• Beijing Lu Daopei Hospital: collaborator
• Hebei Yanda Ludaopei Hospital: collaborator

Study Sites (2)

He bei Yan da Lu dao pei Hospital

Yanda, Hebei, China

RECRUITING

BeiJing Ludaopei Hospital

Beijing, Yizhuang, 100000, China

RECRUITING

Related Publications (1)

• Zhang XG, Wang L, Yang J, Hu XN, Wang H, Zhang LN, Zhou X, Liu Y, Wang Q, Lu PH. Efficacy and safety of BCMA nanobody CAR T-cell therapy in relapsed or refractory plasma cell myeloma. Blood Adv. 2025 Sep 23;9(18):4543-4552. doi: 10.1182/bloodadvances.2025016322.

  PMID: 40569697 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Peihua Lu, PhD&MD

  Beijing Lu Daopei Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peihua Lu, PhD&MD

CONTACT

008618611636172; peihua_lu@126.com

Jianqiang Li, PhD&MD

CONTACT

008615511369555; limmune@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: June 30, 2020
• Primary Completion: August 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 29, 2020

Record last verified: 2020-08

Locations

CN (2)