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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllCRISPR Therapeutics AG
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ18 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.
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What it tests

  • CTX112
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Where

12 sites
Boston Medical Center
Boston, United States
Mayo Clinic in Rochester
Rochester, United States
University of Nebraska Medical Center
Omaha, United States
Universitaetsklinikum Koeln
Cologne, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Germany
UCT University Medical Center Mainz
Mainz, Germany
Hospital Clinic Barcelona
Barcelona, Spain

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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