Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06868290

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

Led by Novartis Pharmaceuticals · Updated on 2026-02-23

126

Participants Needed

31

Research Sites

271 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 to 75 years with a diagnosis of GPA or MPA according to ACR/EULAR 2022 criteria
  • Positive test for ANCA-autoantibodies
  • Participants with severe active GPA or MPA disease
Not Eligible

You will not qualify if you...

  • Conditions preventing complete washout of medications or making participant ineligible for anti-CD19 CAR-T therapy
  • Hypersensitivity or contraindications to any study treatments
  • Having other systemic autoimmune diseases requiring therapy
  • Medical conditions unrelated to GPA/MPA that could affect tolerance of CD19 CAR-T cell therapy
  • Inadequate organ function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 31 locations

1

University Of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

Actively Recruiting

3

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

4

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

5

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

6

Oregon Health Sciences University

Portland, Oregon, United States, 97239

Actively Recruiting

7

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

8

LDS Hospital

Salt Lake City, Utah, United States, 84143

Actively Recruiting

9

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil, 41253-190

Actively Recruiting

10

Novartis Investigative Site

Barretos, São Paulo, Brazil, 14784 400

Actively Recruiting

11

Novartis Investigative Site

São Paulo, São Paulo, Brazil, 01308-050

Actively Recruiting

12

Novartis Investigative Site

São Paulo, Brazil, 01509-010

Actively Recruiting

13

Novartis Investigative Site

Haifa, Israel, 3109601

Actively Recruiting

14

Novartis Investigative Site

Ramat Gan, Israel, 5265601

Actively Recruiting

15

Novartis Investigative Site

Sapporo, Hokkaido, Japan, 0608648

Actively Recruiting

16

Novartis Investigative Site

Kobe, Hyōgo, Japan, 6500047

Actively Recruiting

17

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan, 920 8641

Actively Recruiting

18

Novartis Investigative Site

Sendai, Miyagi, Japan, 9808574

Actively Recruiting

19

Novartis Investigative Site

Suita, Osaka, Japan, 5650871

Actively Recruiting

20

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan, 1138431

Actively Recruiting

21

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan, 1608582

Actively Recruiting

22

Novartis Investigative Site

Chiba, Japan, 260 8677

Actively Recruiting

23

Novartis Investigative Site

Fukuoka, Japan, 8128582

Actively Recruiting

24

Novartis Investigative Site

Kyoto, Japan, 6068507

Actively Recruiting

25

Novartis Investigative Site

Riyadh, Saudi Arabia, 11211

Actively Recruiting

26

Novartis Investigative Site

Singapore, Singapore, 119074

Actively Recruiting

27

Novartis Investigative Site

Singapore, Singapore, S308433

Actively Recruiting

28

Novartis Investigative Site

Basel, Switzerland, 4031

Actively Recruiting

29

Novartis Investigative Site

Bern, Switzerland, 3010

Actively Recruiting

30

Novartis Investigative Site

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

31

Novartis Investigative Site

London, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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