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Clinical Trials in the USA / NCT04155749
Active, not recruiting Phase 1

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

NCT04155749 · tracked via the Priya Life Science USA tracker
Sponsor
Kite, A Gilead Company
Phase
Phase 1
Started
2019-12-23
Last updated
2026-02-11

Condition(s) studied

Relapsed and Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

anitocabtagene-autoleucel →

anitocabtagene-autoleucel: Chimeric Antigen Receptor T cells

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • Incidence of treatment-emergent adverse events (TEAEs), including DLT(s) — 24 months
  • Establish the RP2D of the investigational agent — 24 months

Trial sites (4)

FacilityCityRegionStatus
Advanced Cellular Therapeutics Facility, DCAM 0800A Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
Froedtert Hospital/Medical College of Wisconsin Milwaukee Wisconsin

More Kite, A Gilead Company trials in the USA

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma Active, not recruiting
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma Active, not recruiting
Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1) Active, not recruiting
Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome. Active, not recruiting
Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04155749 on ClinicalTrials.gov ↗ ← All trials in the USA