CAR-T Cells Therapy in Relapsed/Refractory Multiple Myeloma

NCT03473496 | Terminated DMC

• 1 other identifier: 2017-XYNK-003
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, and several clinical trials have been reported in the treatment of multiple myeloma with CAR-T cells.

Conditions

Relapsed/Refractory Multiple Myeloma(MM)

Keywords

BCMA-CART; CD138-CART; CD56-CART; CD38-CART

Outcome Measures

Primary Outcomes (1)

• Adverse events that Are related to treatment

  Determine the toxicity profile of the BCMA/CD138/CD38/CD56-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0

  2 years

Secondary Outcomes (3)

• Estimate 2 year overall survival(OS) after infusion of BCMA/CD138/CD38/CD56-CART and sequential treatment

  2 years

• Estimate 2 year relapse rate after infusion of BCMA/CD138/CD38/CD56-CART and sequential treatment

  2 years

• Estimate 2 year progression free survival after infusion of BCMA/CD138/CD38/CD56-CART and sequential treatment

  2 years

Study Arms (1)

CART therapy in multiple myeloma

EXPERIMENTAL

In order to assess the safety and validity of using CAR-T therapy refractory/rela-psed multiple myeloma patients with one kind of BCMA-CART,CD138-CART,CD56-CART or CD38-CART,subjects will receive 10\^6-10\^7/Kg transduced CAR T cells at one time.

Biological: CART therapy in Relapsed/Refractory multiple myeloma

Interventions

CART therapy in Relapsed/Refractory multiple myeloma BIOLOGICAL

one kind of BCMA/CD138/CD38/CD56-CART therapy in Relapsed/Refractory multiple myeloma

CART therapy in multiple myeloma

Eligibility Criteria

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

You may qualify if:

• Relapsed/Refractory MM patients
• Cell phenotype is BCMA/CD138/CD38/CD56 positive (single or combined) ,and minimal residual disease (MRD) was positive(cytology, genetic testing)
• Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky performance status(KPS) score is more than 60.
• No cytapheresis and cell separation contraindication.
• Hemoglobin is more than 80 gram per litre.
• The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%（EF≥50%）, and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%（SpO2≥90%）;(3)Creatinine（Cr） is less than 2.5 times normal range;(4)Alanine transaminase（ALT） and glutamic-oxalacetic transaminase（AST）is less than 3 times normal range,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL).
• After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk.
• Volunteered for this clinical trail and signed a consent form .

You may not qualify if:

• Patients with high tumor burden or progression of disease need to control the progression of disease in order to decrease the tumor burden.
• Patients with active infection and fever.
• Patients' neutrophilic granulocyte has decreased more than 10 days,and is difficult to control after treatment.
• Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment.
• Patients with infection of HIV or with actively infection of Hepatitis B Virus(HBV) or Hepatitis C Virus(HCV).
• Pregnant or lactating women.
• Patients with severe insufficient cardiac, pulmonary and hepatorenal functions.
• Patients had been treated with cell therapy but was invalid.After analyzing the patient's condition , the expert group think that the patient doesn't fit to attend the therapy of CART.
• The monoclonal antibodies of BCMA or CD38 are invalid for the patients who have used the drug.
• Any situation may do harm to the subjects or interfere the results.
• After allogeneic transplantation, patients are more than 3 degrees of acute Graft-Versus-Host disease(GVHD).

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Nanfang Hospital, Southern Medical University: collaborator
• The Third Affiliated Hospital of Southern Medical University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

Study Sites (1)

Southern Medical University Zhujiang Hospital

Guangdong, Guangdong, 510000, China

Location

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

• Yanjie He

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 22, 2018
• Study Start: March 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 15, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)