Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

NCT05396885 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ARC-112A
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 18

Brief Summary

A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR Per International Myeloma Working Group (IMWG) criteria, as assessed by an independent review committee (IRC)

  24 Months

Secondary Outcomes (13)

• Stringent complete response (sCR) or complete response (CR) rate

  24 Months

• Overall Response Rate (ORR) of participants limited to three lines of prior treatment

  24 Months

• Duration of Response (DoR)

  24 Months

• Very Good Partial Response (VGPR) Rate and Partial Response (PR) Rate

  24 Months

• Time to Initial Response

  24 months

Study Arms (1)

anitocabtagene-autoleucel

EXPERIMENTAL

Single dose of 115±10 x 10e-6 CAR+ anitocabtagene-autoleucel cells infused intravenously

Biological: anitocabtagene-autoleucel

Interventions

anitocabtagene-autoleucel BIOLOGICAL

Anitocabtagene-autoleucel-directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-domain

Also known as: CART-ddBCMA

anitocabtagene-autoleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older and has capacity to give informed consent
• Relapsed or refractory multiple myeloma treated with at least 3 prior regimens of systemic therapy including proteasome inhibitor, immunomodulatory drugs (IMiD) and anti-CD38 antibody and are refractory to the last line of therapy. For each line, 2 consecutive cycles are required unless the best response after 1 cycle was progressive disease.
• Note: IMWG criteria defines refractory disease as non-responsive to therapy or disease progression on or within 60 days of a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen
• Documented measurable disease including at least one or more of the following criteria:
• Serum M-protein ≥1.0 g/dL
• Urine M-protein ≥200 mg/24 hours
• Involved serum free light chain ≥10 mg/dL with abnormal κ/λ ratio (i.e., \>4:1 or \<1:2)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy \>12 weeks
• Adequate organ function defined as:
• Oxygen (O2) saturation ≥92% on room air
• Left Ventricular Ejection Fraction (LVEF) ≥45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
• Absolute neutrophil count (ANC) ≥1.0k/µl, platelet count (PLT)
• ≥50k/µl, \[NOTE: Platelet transfusion not allowed within 14 days; filgrastim (or biosimilar) not allowed within 7 days, pegfilgrastim (or biosimilar) within 14 days\]
• Creatinine clearance ≥45 mL/min min (as determined by the Cockgroft-Gault equation) and not on dialysis

You may not qualify if:

• Plasma cell leukemia or history of plasma cell leukemia
• Treatment with the following therapies as specified below
• Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis
• Receiving high-dose (e.g., \>10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis
• Prior treatment with any gene therapy, gene-modified cellular immune-therapy, or T cell engager
• Prior B-cell maturation antigen (BCMA) directed therapy
• Autologous stem cell transplantation within 3 months prior to leukapheresis, or any prior allogeneic stem cell transplantation
• Subjects with solitary plasmacytomas without evidence of other measurable disease are excluded
• History of allergy or hypersensitivity to study drug components. Subjects with a history of severe hypersensitivity reaction to dimethyl sulphoxide (DMSO) are excluded
• Contraindication to fludarabine or cyclophosphamide
• Severe or uncontrolled intercurrent illness or laboratory abnormalities including
• Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, (e.g., related to disease)
• Symptomatic congestive heart failure (i.e., New York Heart Association stage III or IV)
• Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to Screening
• Significant pulmonary dysfunction

Sponsors & Collaborators

• Kite, A Gilead Company: lead
• Arcellx, Inc.: collaborator

Study Sites (18)

HonorHealth Cancer Transplant Institute

Scottsdale, Arizona, 85258, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States

Location

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Arcellx, Inc.

  Arcellx, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 31, 2022
• Study Start: July 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)