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 : July 31, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsed and Refractory Multiple Myeloma | Drug: CART-ddBCMA | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12 participants |
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 : | November 1, 2020 |
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 |
- Incidence of treatment-emergent adverse events (TEAEs), including DLT(s) [ Time Frame: 24 months ]
- Best overall response (BOR) and ORR by IMWG Consensus Criteria [ Time Frame: 24 months ]

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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: Melissa Sheppard, BSN, RN 773-702-2476 melissa.sheppard@uchospitals.edu | |
Contact: Rebecca Malloy, RN, BSN 773-834-1475 rmallow@medicine.bsd.uchicago.edu | |
Principal Investigator: Michael Bishop, MD | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Matthew Frigault, MD 617-724-4000 mfrigault@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 |
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: | July 31, 2020 |
Last Verified: | July 2020 |
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 |