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

Relapsed and Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04155749
• Other study ID #: ARC-101-ARM-1
• Status: Recruiting
• Phase: Phase 1
• Start date: November 18, 2019
• Est. completion date: November 1, 2035

Study information

• Verified date: March 2024
• Source: Gilead Sciences
• Contact: Arcellx, Inc.
• Phone: 240-327-0379
• Email: clinical[@]arcellx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: November 1, 2035
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed and Refractory Multiple Myeloma

Intervention

Drug:
• anitocabtagene-autoleucel
Chimeric Antigen Receptor T cells
• ARC-T Plus Anti-BCMA SparX
Chimeric Antigen Receptor T cells plus SparX protein

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Kite, A Gilead Company	Arcellx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)		24 months
Primary	Establish the RP2D of the investigational agent		24 months
Secondary	Best overall response (BOR) by IMWG Consensus Criteria		24 months
Secondary	ORR by IMWG Consensus Criteria		24 months
Secondary	In vivo pharmacokinetics	expansion and persistence of investigational agent in peripheral blood/target tissues	24 months