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

Inclusion Criteria

• 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 Criteria

• 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.