Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT04155749 |
Recruitment Status :
Recruiting
First Posted : November 7, 2019
Last Update Posted : August 1, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsed and Refractory Multiple Myeloma | Drug: CART-ddBCMA Drug: ARC-T Plus Anti-BCMA SparX | Phase 1 |
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 (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 |

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
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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 |
- Incidence of treatment-emergent adverse events (TEAEs), including DLT(s) [ Time Frame: 24 months ]
- Establish the RP2D of the investigational agent [ Time Frame: 24 months ]
- Best overall response (BOR) by IMWG Consensus Criteria [ Time Frame: 24 months ]
- ORR by IMWG Consensus Criteria [ Time Frame: 24 months ]
- In vivo pharmacokinetics [ Time Frame: 24 months ]expansion and persistence of investigational agent in peripheral blood/target tissues

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Arcellx, Inc. | 240-327-0379 | clinical@arcellx.com |
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 |
Study Director: | Arcellx, Inc. | Arcellx, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
BCMA Myeloma Chimeric |
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 |