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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Relapsed and Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

anitocabtagene-autoleucel

Intervention Type DRUG

Chimeric Antigen Receptor T cells

Interventions

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anitocabtagene-autoleucel

Chimeric Antigen Receptor T cells

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No