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

Conditions

Relapsed and Refractory Multiple Myeloma

Keywords

BCMA, Myeloma, Chimeric

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.

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10.1182/blood-2025-256

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Phase 1 Study of CART-ddBCMA, a CAR-T therapy utilizing a novel synthetic binding domain, for the treatment of subjects with relapsed and refractory multiple myeloma.

Matthew J. Frigault, Elizabeth O’Donnell, Noopur Raje, Daniella Cook, Andrew J. Yee et al. (20 authors)

Journal of Clinical Oncology2021-05-207 citations

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Phase 1 Study of CART-Ddbcma, a CAR-T Therapy Utilizing a Novel Synthetic Binding Domain for the Treatment of Subjects with Relapsed and Refractory Multiple Myeloma

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Blood2020-11-058 citations

10.1182/blood-2020-142931

Interventions

DRUGanitocabtagene-autoleucel

Chimeric Antigen Receptor T cells

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria	24 months	—
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.

Countries

United States

Contacts

STUDY_DIRECTORArcellx, Inc.

Arcellx, Inc.

Outcome results

None listed