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STATUS Recruitment Complete

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

LAST UPDATED

August 06 2025

Clinicaltrials.gov ID

NCT04155749

OVERVIEW

Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up

PROTOCOL 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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Relapsed and Refractory Multiple Myeloma

Gender

N/A

Date

December 2019 - October 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

anitocabtagene-autoleucel

Eligibility Information

Inclusion

Inclusion Criteria

  • Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system 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
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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 laboratory abnormalities
  • Active central nervous system disease involvement by malignancy or active CNS pathology
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Locations

Locations (4)
Other

Advanced Cellular Therapeutics Facility, DCAM 0800A

Chicago, Illinois, United States, 60637

Other

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Other

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Other

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226