Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma

NCT ID: NCT03448978

Last Updated: 2024-07-01

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2021-06-03

Brief Summary

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This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Detailed Description

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Conditions

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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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Descartes-08 plus fludarabine/cyclophosphamide pretreat

Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

Group Type EXPERIMENTAL

Descartes-08

Intervention Type BIOLOGICAL

autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

Fludarabine

Intervention Type DRUG

intravenous fludarabine

Cyclophosphamide

Intervention Type DRUG

intravenous cyclophosphamide

Interventions

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Descartes-08

autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

Intervention Type BIOLOGICAL

Fludarabine

intravenous fludarabine

Intervention Type DRUG

Cyclophosphamide

intravenous cyclophosphamide

Intervention Type DRUG

Other Intervention Names

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CAR-T cells

Eligibility Criteria

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Inclusion Criteria

* Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
* Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, \>5% bone marrow plasma cells.
* Adequate vital organ function as indicated by ANC (\>1000/uL), platelet count (\>50,000/uL), hemoglobin (\>8 g/dL), serum ALT and AST (each \<3.0 x upper limit of normal), total bilirubin (\<2 mg/dL), creatinine clearance (\>30 mL/min), and cardiac ejection fraction (\>45%)

Exclusion Criteria

NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary

* Active plasma cell leukemia
* Pregnant or lactating
* Active, uncontrolled infection
* Active and severe auto-immune disease
* Active arrhythmia, or obstructive or restrictive pulmonary disease
* Central nervous system disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cartesian Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Metin Kurtoglu, MD, PhD

Role: STUDY_DIRECTOR

Cartesian Therapeutics

Locations

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The Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Virgina Cancer Specialists

Fairfax, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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241-59-88

Identifier Type: -

Identifier Source: org_study_id

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