Clinical trial NCT04155749: Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapsed and Refractory Multiple Myeloma
Keywords: BCMA
Myeloma
Chimeric
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Arcellx, Inc.
First posted: 2019-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)
timeFrame: 24 months
measure: Establish the RP2D of the investigational agent
timeFrame: 24 months
Secondary outcomes:
measure: Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria
timeFrame: 24 months
measure: Overall Response Rate (ORR) by IMWG Consensus Criteria
timeFrame: 24 months
measure: PK Parameter for Anitocabtagene-Autoleucel: Cmax
timeFrame: Day 1 up to 24 months
measure: PK Parameter for Anitocabtagene-autoleucel: Tmax
timeFrame: Day 1 up to 24 months
measure: PK Parameter for Anitocabtagene-Autoleucel: Area under the curve (AUC)
timeFrame: Day 1 up to 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine Comprehensive Cancer Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Arcellx, Inc.
name: Arcellx, Inc.
role: STUDY_DIRECTOR
References:
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.