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NCT Number: NCT04155749

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Relapsed and Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Cellular Therapeutics Facility, DCAM 0800A, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anitocabtagene-autoleucel

Drug

Chimeric Antigen Receptor T cells

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)

    Time frame: 24 months

  2. Establish the RP2D of the investigational agent

    Time frame: 24 months

Secondary outcomes

  1. Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria

    Time frame: 24 months

  2. Overall Response Rate (ORR) by IMWG Consensus Criteria

    Time frame: 24 months

  3. PK Parameter for Anitocabtagene-Autoleucel: Cmax

    Time frame: Day 1 up to 24 months

    Cmax is defined as the maximum observed concentration of drug.

  4. PK Parameter for Anitocabtagene-autoleucel: Tmax

    Time frame: Day 1 up to 24 months

    Tmax is defined as the time (observed time point) of Cmax.

  5. PK Parameter for Anitocabtagene-Autoleucel: Area under the curve (AUC)

    Time frame: Day 1 up to 24 months

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Sponsors and collaborators

Lead sponsor

Kite, A Gilead Company

Industry

Collaborators

  • Arcellx, Inc.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2027
First posted
Nov 7, 2019
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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