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

June 28, 2024 updated by: Cartesian Therapeutics

Phase I Safety and Feasibility Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • The Center for Cancer and Blood Disorders
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virgina Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (condensed):

  • 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 (condensed):

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Descartes-08 plus fludarabine/cyclophosphamide pretreat
Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Biological: Descartes-08
autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
Other Names:
  • CAR-T cells
Drug: Fludarabine
intravenous fludarabine
Drug: Cyclophosphamide
intravenous cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 2 weeks
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]. Descriptive statistics by incidence rate, body system classification, severity, and causality [per protocol definitions]
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response
Time Frame: 1, 3, 6, 9 and 12 months
IMWG treatment response criteria
1, 3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cartesian Therapeutics

Investigators

  • Study Director: Metin Kurtoglu, MD, PhD, Cartesian Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2018

Primary Completion (Actual)

April 19, 2021

Study Completion (Actual)

June 3, 2021

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 241-59-88

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Descartes-08

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe