Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematolo… (NCT07549698) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
60 participantsStarted 2026-04
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
To evaluate the safety of CTX112 in adult participants with refractory hematologic autoimmune diseases, including ITP or wAIHA.
Timeframe: From CTX112 infusion up to 28 days post infusion.