CTX112 (zugo-cel) for relapsed/refractory ITP and wAIHA in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, single-arm Phase 1/2 study evaluating the safety and early signals of efficacy for CTX112 (zugo-cel) in adults with relapsed or refractory primary ITP or primary wAIHA. CTX112 is an allogeneic CD19-targeted CAR-T cell product derived from healthy donors and modified ex vivo. The study explores ascending dose levels to identify tolerability and potential clinical benefit, with up to 60 participants over up to five years. Primary endpoints focus on safety, with secondary endpoints examining preliminary efficacy and disease activity markers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years.
2. Participants must voluntarily sign a written informed consent and be willing and able to comply with all trial requirements.
3. Adequate hematologic, renal, liver, cardiac and pulmonary function.
4. Participants must agree to use acceptable methods of contraception.
5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other trial procedures.
6. Diagnosis of relapsed/refractory primary Immune Thrombocytopenic Purpura (ITP) or Warm Autoimmune Hemolytic Anemia (WAIHA)

Exclusion Criteria:

1. Prior treatment with anti-CD19 therapy or any gene therapy or genetically modified cell therapy.
2. Prior solid organ (e.g., heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
3. Severe active or history of central nervous (CNS) involvement.
4. 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.
5. History of primary or secondary immunodeficiency.
6. Presence or history of certain bacterial, viral or fungal infection
7. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence).
8. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome.
9. History or current diagnosis that requires uninterrupted, ongoing anticoagulation.
10. Pregnant or lactating.
11. 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.

Where it's running

• Boston Medical Center
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• Universitaetsklinikum Koeln
  Cologne, Germany Recruiting
• Universitaetsklinikum Carl Gustav Carus Dresden
  Dresden, Germany Recruiting
• Medizinische Hochschule Hannover (MHH)
  Hanover, Germany Recruiting

Study contacts

• Study coordinator: Clinical Trials
• Email: medicalaffairs@crisprtx.com
• Phone: 877-214-4634

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for patients with Primary Immune Thrombocytopenia in Spain

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.