Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA

Conditions

• ANCA Associated Vasculitis (AAV)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Rapcabtagene autoleucel — BIOLOGICAL
  Single infusion of rapcabtagene autoleucel
• Active Comparator — OTHER
  Active comparator option as per protocol
• Glucocorticoids — DRUG
  Concomitant glucocorticoids as per protocol

Study Details

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)

Key Dates

Start date

Mar 13, 2025

Status verified

May 2026

Primary completion

Jun 7, 2029

Completion

May 24, 2030

Study Design

Enrollment

126 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rapcabtagene autoleucel
  Single infusion of rapcabtagene autoleucel (YTB323) and concomitant glucocorticoids as per protocol
• Active Comparator: Active comparator
  Comparator and concomitant glucocorticoids as per protocol

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111
  [email protected]

Locations (11)

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