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RECRUITING
NCT07549698
PHASE1/PHASE2

Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease

Sponsor: CRISPR Therapeutics AG

View on ClinicalTrials.gov

Summary

This is a single-arm, open-label, multicenter, ascending dose Phase 1/2 trial evaluating the safety and preliminary efficacy of CTX112 or Zugocabtagene geleucel (zugo-cel) in adult participants with relapsed/refractory primary Immune Thrombocytopenia (ITP) and relapsed/refractory primary Warm Autoimmune Hemolytic Anemia (wAIHA).

Official title: A Phase 1/2 Dose Evaluation Trial of the Safety and Preliminary Efficacy of Anti CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-06

Completion Date

2033-12

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

BIOLOGICAL

CTX112

CTX112 (zugo-cel): CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components

Locations (10)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Universitaetsklinikum Koeln

Cologne, Germany

Medizinische Hochschule Hannover

Hannover, Germany

Medizinische Hochschule Hannover (MHH)

Hanover, Germany

UCT University Medical Center Mainz

Mainz, Germany

Hospital Universitario Reina Sofia

Córdoba, Spain

Gregorio Marañón General University Hospital

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain