Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease

Recruiting now · Phase 1/Phase 2

Conditions studied: Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Immune Thrombocytopenic Purpura

In brief

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).

Key facts

Study ID

NCT07549698

Run by

CRISPR Therapeutics AG

People needed

60

Starts

2026-06-01

Expected to finish

2033-12-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.
• Severe active or history of central nervous (CNS) involvement.
• 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.
• 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.
• History or current diagnosis that requires uninterrupted, ongoing anticoagulation.
• Pregnant or lactating.
• 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 is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Universitaetsklinikum Koeln — Cologne, Germany (enrolling)
• Hospital Universitario Reina Sofia — Córdoba, Spain (enrolling)
• Gregorio Marañón General University Hospital — Madrid, Spain (enrolling)
• Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
• Hospital Universitario La Paz — Madrid, Spain
• Medizinische Hochschule Hannover — Hannover, Germany
• Medizinische Hochschule Hannover (MHH) — Hanover, Germany
• UCT University Medical Center Mainz — Mainz, Germany

Full record on ClinicalTrials.gov

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