Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Dec 22, 2026
  • participants needed
    10
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 22 January 2021
cancer
lymphoid leukemia
lymphoma
cell transplantation
leukemia
refractory multiple myeloma
bcma

Summary

Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).

Description

Adults ages 18-75 with Relapsed and/or Chemotherapy Refractory Multiple Myelomas.

Design

Participants may be screened with:

Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Lymphocytes are collected by apheresis from the enrolled patient or a healthy donor. Blood is removed through a needle in an arm. The rest of the blood is returned through a needle in the other arm.

The cells will be changed in a laboratory. Participants will get 2 chemotherapy drugs over 5 days. Two days later, participants will get an intravenous (IV) catheter in an arm. They will get the split doses CART cells on day0, day1, day2 through the IV in 1 infusion.

After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.

Participants will visit the clinic at 1, 2, 3, 6, 9 and 12 months after the infusion, then every 6 months until two years after infusion. A bone marrow sample will be taken at the 3-month visit.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment CART-138/BCMA/19/more
Clinical Study IdentifierNCT03196414
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT)
Relapsed and/or refractory multiple myeloma
Relapsed after prior autologous or allogenic SCT
Expected survival 3 months
Creatinine < 2.0 mg/dl
Blood coagulation function: PT and APTT < 2x normal
Arterial blood oxygen saturation > 92%
Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) < 3x normal
Karnofsky scores 60 and ECOG score 2
Adequate venous access for apheresis, and no other contraindications for leukapheresis
Patients should not take system chemotherapy in one month and immunotherapy in three months prior to CART cells infusion
Voluntary informed consent is given

Exclusion Criteria

Pregnant or lactating women
Uncontrolled active infection
Active hepatitis B or hepatitis C infection
Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
Previously treatment with any gene therapy products
Any uncontrolled active medical disorder that would preclude participation as outlined
HIV infection
History of myocardial infarction and severe arrhythmia in half a year
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
Patients with fever of unknown origin (T > 38)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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