Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
A legfontosabb adatok
- Hol
- Boston, Omaha és Rochester (Egyesült Államok)Mind a 3 helyszín megnézése
- Fázis
- 1/2. fázis
Helyszínek itt: Egyesült Államok
- Boston Medical CenterBoston, Egyesült ÁllamokContact: Fabio Petrocca, MD (principal investigator)Résztvevőt keres
- University of Nebraska Medical CenterOmaha, Egyesült ÁllamokContact: Marcel Devetten, MD (principal investigator)Résztvevőt keres
- Mayo Clinic in RochesterRochester, Egyesült ÁllamokContact: Jithma Abeykoon, MD (principal investigator)Résztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- CRISPR Therapeutics AG
- Azonosító
- NCT07549698
- A regiszteradat frissítve
- 2026. október 20.
- Eredeti leírás
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).A teljes eredeti leírásKevesebb
A Phase 1/2 Dose Evaluation Trial of the Safety and Preliminary Efficacy of Anti CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
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).
Bevonási feltételek: 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).
Kizáró feltételek: 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; 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; Severe active or history of central nervous (CNS) involvement; 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; 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; History or current diagnosis that requires uninterrupted, ongoing anticoagulation; Pregnant or lactating.