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

February 9, 2026 updated by: Kite, A Gilead Company

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

ARM 1 is a non-randomized, open label, multi-site Phase 1 study. CART-ddBCMA is a BCMA directed CAR with a non-scFv binding domain that has been deimmunized.

ARM 2 is a non-randomized, open label, multi-site Phase 1 study. Using the bivalent BCMA-Specific Adapter (SPRX001) and Universal CAR-Modified T cell (ARC-T Cells)

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Advanced Cellular Therapeutics Facility, DCAM 0800A
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital/Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM 1
Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma
Drug: anitocabtagene-autoleucel
Chimeric Antigen Receptor T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)
Time Frame: 24 months
24 months
Establish the RP2D of the investigational agent
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria
Time Frame: 24 months
24 months
Overall Response Rate (ORR) by IMWG Consensus Criteria
Time Frame: 24 months
24 months
PK Parameter for Anitocabtagene-Autoleucel: Cmax
Time Frame: Day 1 up to 24 months
Cmax is defined as the maximum observed concentration of drug.
Day 1 up to 24 months
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.
Day 1 up to 24 months
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.
Day 1 up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kite, A Gilead Company

Collaborators

Arcellx, Inc.

Investigators

  • Study Director: Arcellx, Inc., Arcellx, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2019

Primary Completion (Actual)

October 3, 2024

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

October 17, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC-101-ARM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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