Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma

Phase 1

Active, not recruiting

• Conditions: Relapsed and Refractory Multiple Myeloma
• Interventions: Drug: anitocabtagene-autoleucel

• Registration Number: NCT04155749
• Lead Sponsor: Kite, A Gilead Company

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2019-12-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-08-31
• Study Completion: 2035-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM 1	anitocabtagene-autoleucel	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

Primary Outcome Measures

Name	Time	Method
Establish the RP2D of the investigational agent	24 months
Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)	24 months

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR) by IMWG Consensus Criteria	24 months
PK Parameter for Anitocabtagene-Autoleucel: Cmax	Day 1 up to 24 months	Cmax is defined as the maximum observed concentration of drug.
PK Parameter for Anitocabtagene-autoleucel: Tmax	Day 1 up to 24 months	Tmax is defined as the time (observed time point) of Cmax.
PK Parameter for Anitocabtagene-Autoleucel: Area under the curve (AUC)	Day 1 up to 24 months	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria	24 months

Trial Locations

Locations (4)

University of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States