Anti-BCMA CAR-NK Therapy in Relapsed or Refractory Multiple Myeloma

Last updated: March 3, 2024
Sponsor: Shahid Beheshti University of Medical Sciences
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Multiple Myeloma

Red Blood Cell Disorders

Leukemia

Treatment

Anti-BCMA CAR-NK

Clinical Study ID

NCT06242249
74932
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Immunotherapy has shown promise in the treatment of hematological malignancies, including multiple myeloma. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain in terms of antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including BCMA, with CAR-NK cells in multiple myeloma. To further investigate the potential of BCMA-targeted CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-80 years with expected survival > 3 months.
  2. Confirmed diagnosis of active multiple myeloma with detectable BCMA expression inmalignant cells.
  3. Relapsed or refractory disease with at least 2 prior lines of treatment, including aproteasome inhibitor and immunomodulator, without achieving significant efficacy.
  4. Measurable disease at screening according to IMWG criteria, as defined by any of thefollowing: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-proteinlevel being as defined； or light chain MM without measurable disease in the serum orthe urine； serum immunoglobulin free light chain disease dL and abnormal serumimmunoglobulin kappa/lambda free light chain ratio
  5. ECOG performance status of 0-1.
  6. Acceptable cardiac, liver, and kidney function.
  7. Signed written informed consent.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Uncontrolled active infection, HIV infection, or positive syphilis serology reaction.
  3. Active hepatitis B or hepatitis C infection.
  4. Recent or current use of glucocorticoids or other immunosuppressors.
  5. Severe cardiac, liver, renal insufficiency, diabetes, or other diseases.
  6. Participation in other clinical research in the past three months.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Anti-BCMA CAR-NK
Phase: 1/2
Study Start date:
April 30, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Shariati Hospital

    Tehran,
    Iran, Islamic Republic of

    Site Not Available

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