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Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Sponsor: CRISPR Therapeutics AG
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
Conditions
Interventions
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