Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma

Last updated: February 9, 2026
Sponsor: Kite, A Gilead Company
Overall Status: Active - Not Recruiting

Phase

1

Condition

Leukemia

Cancer/tumors

Lymphoproliferative Disorders

Treatment

CART-ddBCMA

anitocabtagene-autoleucel

ARC-T Plus Anti-BCMA SparX

Clinical Study ID

NCT04155749
ARC-101-ARM1
  • Ages > 18
  • All Genders

Study Summary

Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens ofsystem therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD),and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease

  • Documented measurable disease

  • Adequate organ function

  • Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1

Exclusion

Exclusion Criteria:

  • Plasma Cell Leukemia or History of Plasma Cell Leukemia

  • Patients with a history of severe hypersensitivity to DMSO should be excluded

  • Contraindication to fludarabine or cyclophosphamide

  • Severe uncontrolled intercurrent illness (e.g., infection) or laboratoryabnormalities

  • Active central nervous system disease involvement by malignancy or active CNSpathology

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: CART-ddBCMA
Phase: 1
Study Start date:
December 23, 2019
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Advanced Cellular Therapeutics Facility, DCAM 0800A

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Advanced Cellular Therapeutics Facility, DCAM 0800A

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Froedtert Hospital/Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Froedtert Hospital/Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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