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).
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.
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.