Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis

Conditions

• Myasthaenia Gravis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Decartes-08 — BIOLOGICAL
  Autologous mRNA CAR T-cell therapy
• Placebo Drug — OTHER
  infusion without Decartes-08

Study Details

The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults with acetylcholine receptor autoantibody -positive generalized myasthenia gravis. Part 1 of the study will last around 6 months. For eligible participants, Part 2 will last around 8 months.

Key Dates

Start date

May 6, 2025

Status verified

Mar 2026

Primary completion

Nov 30, 2026

Completion

Sep 30, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Decartes-08
  This group will undergo leukapheresis and receive manufactured Decartes-08
• Placebo Comparator: Placebo
  This group will receive placebo

Primary Outcome Measure

Myasthenia Gravis Activities of Daily Living (MG-ADL) [ Time Frame: assessment at 4 months of study ]

Central Contacts

• Cartesian Clinical Trials
  617-231-8102
  [email protected]

Locations (23)

Find similar trials in Tucson, AZ

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