Taking people in United StatesPhase 1/2
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Key facts
- Who runs it
- CRISPR Therapeutics AG
- Where
- Boston, Omaha, and Rochester, United StatesSee the 3 sitesAlso in 2 other countries, 9 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 60 people, planned
- Started
- 17 Jul 2026
- Expected to end
- Dec 2033
- Type of study
- Interventional
- Treatments tested
- CTX112
- Record updated
- 20 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
Where in United States
Also in 2 other countries, 9 sites
- Boston Medical CenterBoston, United StatesContact: Fabio Petrocca, MD (principal investigator)Taking people
- University of Nebraska Medical CenterOmaha, United StatesContact: Marcel Devetten, MD (principal investigator)Taking people
- Mayo Clinic in RochesterRochester, United StatesContact: Jithma Abeykoon, MD (principal investigator)Taking people
About the trial
What the trial wants to find out
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).
The group in the trial
- CTX112 (zugo-cel)Treatment being tested
Administered by IV infusion following lymphodepleting chemotherapy
Treatment: CTX112
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 20 October 2026