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

NCT04626752 | Unknown Early Phase 1

• 1 other identifier: CAR-T for Multiple myeloma
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Severe/Adverse Events as a Measure of Safety

  Number of Participants with Severe/Adverse Events as a Measure of Safety

  28 days

• CAR-T Cell expansion level

  Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

  24 months

Secondary Outcomes (2)

• Objective response rate of complete remission and partial remission

  24 months

• Overall survival time

  24 months

Study Arms (1)

volunteers

EXPERIMENTAL

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; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

BCMA CAR-T DRUG

Volunteers will be treated with BCMA CAR-T cells

Also known as: senl_BCMA

volunteers

Fludarabine DRUG

25mg/㎡ for D-4、D-3 and D-2

Also known as: flu

volunteers

Cyclophosphamide DRUG

500mg/㎡ for D-3 and D-2

Also known as: ctx

volunteers

Eligibility Criteria

• Age: 18 Years - 75 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

Study Sites (1)

the Second Hospital of HeBei Medical University (HBMU)

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

fludarabine; Influenza Vaccines; Cyclophosphamide; Cholestanetriol 26-Monooxygenase

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytochrome P450 Family 27; Cytochrome P-450 Enzyme System; Cytochromes; Enzymes and Coenzymes; Steroid Hydroxylases; Mixed Function Oxygenases; Oxygenases; Oxidoreductases; Enzymes; Hemeproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jianmin Luo, PhD&MD

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiang Li, PhD&MD

CONTACT

+8631189928689; limmune@gmail.com

Jianmin Luo, PhD&MD

CONTACT

+8631166002304

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 13, 2020
• Study Start: April 1, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)