ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03448978
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Descartes-08 Drug: Fludarabine Drug: Cyclophosphamide Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : February 26, 2019
Estimated Study Completion Date : March 1, 2020


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 Name: CAR-T cells

Drug: Fludarabine
intravenous fludarabine

Drug: Cyclophosphamide
intravenous cyclophosphamide




Primary Outcome Measures :
  1. 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]


Secondary Outcome Measures :
  1. Treatment response [ Time Frame: 1, 3, 6, 9 and 12 months ]
    IMWG treatment response criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  • 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
  • Prior allo-tranplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448978


Contacts
Contact: Cartesian Coordinator for Clinical Trials 302-648-6497 trials@cartesiantx.com

Locations
United States, District of Columbia
Georgetown University Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
United States, Maryland
The Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
United States, Virginia
Virgina Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Cartesian Therapeutics
Investigators
Study Director: Metin Kurtoglu, MD, PhD Cartesian Therapeutics

Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT03448978     History of Changes
Other Study ID Numbers: 241-59-88
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cartesian Therapeutics:
Descartes-08
CAR T Cell
CART
CAR-T
CAR T-Cell
Multiple Myeloma
BCMA
B-cell maturation antigen
B cell maturation antigen

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine phosphate
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites