Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT

  • STATUS
    Recruiting
  • End date
    Dec 29, 2023
  • participants needed
    15
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 29 May 2021

Summary

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 high risk multiple myeloma after auto-HSCT.To test the safety and efficacy of giving targeting CD19 and BCMA T cells in treating high risk multiple myeloma followed with auto-HSCT.

Description

Adults ages 18-75 with high risk Multiple Myelomas (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment).

Design

Participants may be screened with:

Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. 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 auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the T cells through the IV within 3 days. Maintenance therapy with IMiDs was received after combined CAR T 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 1, 2, 3, 6, 9 and 12 months after the infusion, then every 3 months until disease progression. A bone marrow sample will be taken at the 3-month visit.

Details
Condition Safety and Efficacy
Treatment CART-19/BCMA, CART-anti-CD19/BCMA, anti-CD19 and anti-BCMA CAR, Immunomodulatory drugs
Clinical Study IdentifierNCT03455972
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on29 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Multiple myeloma patients eligible for auto-HSCT
High risk multiple myeloma (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment)
Expected survival 3 months
Creatinine < 2.0 mg/dl
Blood coagulation function: PT and APTT <2x normal
Arterial blood oxygen saturation>92%
ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal
Karnofsky scores 60 and ECOG score2
Adequate venous access for apheresis, and no other contraindications for leukapheresis
Patients should not take 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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