Study of CD8+ anti-BCMA CAR T-cells in Patients with Multiple Myeloma

Overview

The main purpose of this study is to evaluate the safety of an investigational CAR-T cell therapy called Descartes-08. The study will also explore whether Descartes-08 provides any treatment benefit in patients with Multiple Myeloma.

SparkCures ID 943
Trial Phase Phase 1
Enrollment 15 Patients
Treatments
Tags
Trial Sponsors
  • Cartesian Therapeutics
NCT Identifier

NCT03448978

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

  • Patients 18 years and older
  • Patients with prior CAR-T therapy and prior anti-BCMA therapy are allowed.
  • 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 defined as a serum M-protein > 0.5 mg/dL or a urine M-protein > 200mg/24 hours or biopsy-proven plasmacytoma or greater than 5% bone marrow plasma cells.
  • Adequate vital organ function as indicated by absolute neutrophil count > 1000/ mm3, platelets > 50,000/mm3, normal cardiac function, ALT/AST levels lower than or equal to 3-fold of normal, creatinine clearance greater than or equal to 30mL/min or 30mL/min/1.73m2, no active infection, and informed consent, including at least one bone marrow biopsy
  • Patients with plasma cell leukemia are not eligible
  • Patients are not eligible if they have any active and uncontrolled infection

The following criteria is provided for health care professionals.

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 < 2.5 3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (> 60 30 mL/min), and cardiac ejection fraction (> 50 45%)

Exclusion Criteria (condensed):

  • 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more


University of Oklahoma Health Sciences Center

Oklahoma City, OK

West Cancer Center Memphis Professional Building

Memphis, TN

Connecticut
Maryland
Montana
New Jersey
Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

Oklahoma
University of Oklahoma Health Sciences Center

Oklahoma City, OK

Tennessee
West Cancer Center Memphis Professional Building

Memphis, TN

Virginia
Washington, D.C.

Resources

There are no resources, links or videos to display for this clinical trial.

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