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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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