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Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155749
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Arcellx, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Relapsed and Refractory Multiple Myeloma Drug: CART-ddBCMA Drug: ARC-T Plus Anti-BCMA SparX Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : November 1, 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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: CART-ddBCMA
Chimeric Antigen Receptor T cells
Experimental: Arm 2
Phase 1 Study of Bivalent BCMA-Specific Adapter (SPRX001) and Universal CAR-Modified T cell (ARC-T Cells) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
 Drug: ARC-T Plus Anti-BCMA SparX
Chimeric Antigen Receptor T cells plus SparX protein


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Best overall response (BOR) by IMWG Consensus Criteria [ Time Frame: 24 months ]
  2. ORR by IMWG Consensus Criteria [ Time Frame: 24 months ]
  3. In vivo pharmacokinetics [ Time Frame: 24 months ]
    expansion and persistence of investigational agent in peripheral blood/target tissues


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155749


Contacts
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Contact: Arcellx, Inc. 240-327-0379 clinical@arcellx.com

Locations
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United States, Illinois
University of Chicago Medicine Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Yougeesh Prabhakar    773-702-0376    yougeesh.prabhakar@bsd.uchicago.edu   
Principal Investigator: Michael Bishop, MD         
Sub-Investigator: Andre Jakubowiak, MD, PhD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniella Cook    714-307-8479    dtcook@partners.org   
Principal Investigator: Matthew Frigault, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Emma Logan, BSN, RN, OCN    617-667-5984    eklogan@bidmc.harvard.edu   
Principal Investigator: Jacalyn Rosenblatt, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Danielle Nissen    414-805-0581    dnissen@mcw.edu   
Principal Investigator: Binod Dhakal, MD         
Sponsors and Collaborators
Arcellx, Inc.
Investigators
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Study Director: Arcellx, Inc. Arcellx, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arcellx, Inc.
ClinicalTrials.gov Identifier: NCT04155749    
Other Study ID Numbers: ARC-101
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arcellx, Inc.:
BCMA
Myeloma
Chimeric
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases