Clinical Trials /

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

NCT03448978

Description:

This Phase I/II 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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
  • Official Title: Combined Phase I-Phase II Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: 241-59-88
  • NCT ID: NCT03448978

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
Descartes-08CAR-T cellsDescartes-08 plus fludarabine/cyclophosphamide pretreat
FludarabineDescartes-08 plus fludarabine/cyclophosphamide pretreat
CyclophosphamideDescartes-08 plus fludarabine/cyclophosphamide pretreat

Purpose

This Phase I/II 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.

Trial Arms

NameTypeDescriptionInterventions
Descartes-08 plus fludarabine/cyclophosphamide pretreatExperimentalAutologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
  • Descartes-08
  • Fludarabine
  • Cyclophosphamide

Eligibility 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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame:2 weeks
Safety Issue:
Description: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

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cartesian Therapeutics

Trial Keywords

  • Descartes-08
  • CAR T Cell
  • CART
  • CAR-T
  • CAR T-Cell
  • Multiple Myeloma
  • BCMA
  • B-cell maturation antigen
  • B cell maturation antigen

Last Updated

June 3, 2019