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

Primary Purpose

Relapsed and Refractory Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CART-ddBCMA
ARC-T Plus Anti-BCMA SparX
Sponsored by
Arcellx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed and Refractory Multiple Myeloma focused on measuring BCMA, Myeloma, Chimeric

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Medicine Comprehensive Cancer Center
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ARM 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Best overall response (BOR) by IMWG Consensus Criteria
ORR by IMWG Consensus Criteria
In vivo pharmacokinetics
expansion and persistence of investigational agent in peripheral blood/target tissues

Full Information

First Posted
October 17, 2019
Last Updated
July 10, 2023
Sponsor
Arcellx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04155749
Brief Title
Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
November 1, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcellx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed and Refractory Multiple Myeloma
Keywords
BCMA, Myeloma, Chimeric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM 1
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CART-ddBCMA
Intervention Description
Chimeric Antigen Receptor T cells
Intervention Type
Drug
Intervention Name(s)
ARC-T Plus Anti-BCMA SparX
Intervention Description
Chimeric Antigen Receptor T cells plus SparX protein
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)
Time Frame
24 months
Title
Establish the RP2D of the investigational agent
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Best overall response (BOR) by IMWG Consensus Criteria
Time Frame
24 months
Title
ORR by IMWG Consensus Criteria
Time Frame
24 months
Title
In vivo pharmacokinetics
Description
expansion and persistence of investigational agent in peripheral blood/target tissues
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arcellx, Inc.
Phone
240-327-0379
Email
clinical@arcellx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arcellx, Inc.
Organizational Affiliation
Arcellx, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Chicago Medicine Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniella Cook
Phone
714-307-8479
Email
dtcook@partners.org
First Name & Middle Initial & Last Name & Degree
Matthew Frigault, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Logan, BSN, RN, OCN
Phone
617-667-5984
Email
eklogan@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jacalyn Rosenblatt, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Nissen
Phone
414-805-0581
Email
dnissen@mcw.edu
First Name & Middle Initial & Last Name & Degree
Binod Dhakal, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35737298
Citation
Buonato JM, Edwards JP, Zaritskaya L, Witter AR, Gupta A, LaFleur DW, Tice DA, Richman LK, Hilbert DM. Preclinical Efficacy of BCMA-Directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain. Mol Cancer Ther. 2022 Jul 5;21(7):1171-1183. doi: 10.1158/1535-7163.MCT-21-0552.
Results Reference
derived

Learn more about this trial

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

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