Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis

Conditions

• Scleroderma, Diffuse

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• rapcabtagene autoleucel — BIOLOGICAL
  single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.
• rituximab — BIOLOGICAL
  rituximab intravenous infusion (i.v.) as per protocol

Study Details

The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.

Key Dates

First listed

Oct 24, 2024

Start date

Oct 29, 2024

Status verified

Aug 2026

Primary completion

Nov 30, 2028

Completion

Aug 30, 2032

Study Design

Enrollment

96 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: rapcabtagene autoleucel arm
  rapcabtagene autoleucel
• Active Comparator: rituximab arm
  rituximab

Primary Outcome Measure

Achievement of a treatment response as per the Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) definition at Week 52. [ Time Frame: Week 52 ]

Locations (13)

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