Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Key facts
- Where
- Cologne, Dresden, Hanover, and Mainz, GermanySee the 4 sites
- Phase
- Phase 1/2
Where in Germany
- Universitaetsklinikum KoelnCologne, GermanyContact: Ruth Flümann, MD (principal investigator)Taking people
- Universitaetsklinikum Carl Gustav Carus DresdenDresden, GermanyContact: Karolin Trautmann-Grill, MD (principal investigator)Taking people
- Medizinische Hochschule Hannover (MHH)Hanover, GermanyContact: Christian Schultze-Florey, MD (principal investigator)Taking people
- UCT University Medical Center MainzMainz, GermanyContact: Eva Wagner-Drouet, MD (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- CRISPR Therapeutics AG
- Trial code
- NCT07549698
- Record updated
- 20 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Age ≥18 years; Participants must voluntarily sign a written informed consent and be willing and able to comply with all trial requirements; Adequate hematologic, renal, liver, cardiac and pulmonary function; Participants must agree to use acceptable methods of contraception; Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other trial procedures; Diagnosis of relapsed/refractory primary Immune Thrombocytopenic Purpura (ITP) or Warm Autoimmune Hemolytic Anemia (WAIHA).
Exclusion: Prior treatment with anti-CD19 therapy or any gene therapy or genetically modified cell therapy; Prior solid organ (e.g., heart, liver, kidney, lung) transplant or hematopoietic cell transplant; Presence of other active autoimmune disease or other conditions that are likely to pose increased safety risks and/or confound disease assessments, or pose significant risk to those receiving CAR T cell therapy; Severe active or history of central nervous (CNS) involvement; History of primary or secondary immunodeficiency; Presence or history of certain bacterial, viral or fungal infection; Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence); Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome; Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol; History or current diagnosis that requires uninterrupted, ongoing anticoagulation; Pregnant or lactating.