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Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)

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ClinicalTrials.gov Identifier: NCT04146051
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Tracking Information
First Submitted Date  ICMJE October 29, 2019
First Posted Date  ICMJE October 31, 2019
Last Update Posted Date February 6, 2024
Actual Study Start Date  ICMJE December 4, 2019
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2022)		 Myasthenia Gravis -Activities of Daily Living Score [ Time Frame: Day 0 to Day 85 ]
In Part 3, the primary objective is to compare the effect of Descartes-08 versus placebo, as measured by the change in MG ADL score from baseline to Week 12. In Part 1, up to three ascending doses of Descartes-08 will be administered to each of 3 to 6 patients; the patients will be staggered at least 21 days apart and will complete a safety review between each dose. In Part 2, patients will receive up to 6 doses in three different schedules depending on the arm they were enrolled into and will be monitored for up to 1 year to assess the safety and tolerability of a repeated dosing schedule.
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)		 Maximum Tolerated Dose [ Time Frame: 28 days ]
Maximum Tolerated Dose (MTD)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2022)
  • Comparison on Descartes-08 versus placebo on QMG, MG QoL 15R, MG Composite, MG PIS [ Time Frame: Day 0 to Day 85 ]
    Compare the effect of Descartes-08 versus placebo on QMG, MG QoL 15R, MG Composite, and MG PIS (change from baseline to Week 12) for all randomized patients (Part 3 only).
  • Comparison on Descartes-08 versus placebo on MG assessments in crossover patients [ Time Frame: Day 0 to Day 85 ]
    Compare the effect of Descartes-08 versus placebo on MG ADL, QMG, MG QoL 15R, MG Composite, and MG PIS (change from baseline to Week 12) in patients who cross over from placebo to Descartes-08 (Part 3 only).
  • Change in titer of myasthenia specific autoantibody titers [ Time Frame: Day 0 to Day 168 ]
    Determine the change from baseline over a period of 24 weeks in the titer of myasthenia specific autoantibody titers, e.g. nicotinic acetylcholine receptor autoantibody (anti-nAChR) or muscle-specific tyrosine kinase autoantibody (anti- MusK or anti-Low-Density-Lipoprotein-Related-Protein4 (anti-LRP4) or anti-AChR cluster antibody and the 4 Immunoglobulin types (IgG, IgM, IgA, IgE) following single or multiple infusions of Descartes-08 in MG auto-antibody seropositive patients (Parts 1 and 2 only)
  • Effect of single or multiple infusions of Descartes-08 on patients by standard clinical assessment scales [ Time Frame: Day 0 to Day 168 ]
    Quantify the clinical effect of single or multiple infusions of Descartes-08 on patients by standard clinical assessment scales (MG ADL, QMG, MG QoL 15R, MG PIS, MG Composite) over a period of 24 weeks in MG auto-antibody seropositive and seronegative patients together and separately (all parts).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)		 MG-ADL Score [ Time Frame: Day 0 to Day 168 ]
Change in Myasthenia Gravis of Daily Living Score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)
Official Title  ICMJE Autologous T-Cells Expressing A Chimeric Antigen Receptor Directed To B-Cell Maturation Antigen (BCMA) In Patients With Generalized Myasthenia Gravis (MG)
Brief Summary This is a Phase IIb study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myasthenia Gravis, Generalized
Intervention  ICMJE Drug: Descartes-08
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Study Arms  ICMJE
  • Experimental: Phase 1b Dose-Escalation
    Generalized Myasthenia Gravis
    Intervention: Drug: Descartes-08
  • Experimental: Phase IIa Expansion
    Generalized Myasthenia Gravis
    Intervention: Drug: Descartes-08
  • Placebo Comparator: Phase IIb Randomized Control Trial
    Generalized Myasthenia Gravis
    Intervention: Drug: Descartes-08
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2022)		 30
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2019)		 18
Estimated Study Completion Date  ICMJE March 31, 2026
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must be at least 18 years of age.
  • Patient must have Generalized Myasthenia Gravis at the time of screening.
  • Concomitant immunosuppressive drugs must be deemed necessary by the investigator.
  • Seronegative Patients are included

Exclusion Criteria:

  • Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient.
  • Patient is pregnant or lactating.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Trial Central Mailbox 302-648-6497 trials@cartesiantx.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04146051
Other Study ID Numbers  ICMJE MG-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cartesian Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cartesian Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cartesian Therapeutics
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP