NCT07549698 Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
| NCT ID | NCT07549698 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CRISPR Therapeutics AG |
| Condition | Warm Autoimmune Hemolytic Anemia (WAIHA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-07-17 |
| Primary Completion | 2033-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-07-17 with a primary completion date of 2033-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07549698 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Warm Autoimmune Hemolytic Anemia (WAIHA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07549698 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07549698 currently recruiting?
Yes, NCT07549698 is actively recruiting participants. Contact the research team at medicalaffairs@crisprtx.com for enrollment information.
Where is the NCT07549698 trial being conducted?
This trial is being conducted at Boston, United States, Rochester, United States, Omaha, United States, Cologne, Germany and 8 additional locations.
Who is sponsoring the NCT07549698 clinical trial?
NCT07549698 is sponsored by CRISPR Therapeutics AG. The trial plans to enroll 60 participants.