Warm Autoimmune Hemolytic Anemia study: CTX112
Official title Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
ClinicalTrials.gov ID: NCT07549698
What this study is testing
What is CTX112?
This is an investigational cell therapy being studied as a potential treatment for warm autoimmune hemolytic anemia. It is designed to use healthy donor T cells that have been changed in a lab to target and remove specific B cells in the body.
Also referred to as Zugocabtagene geleucel, zugo-cel.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if CTX112 is safe and if it helps people whose ITP or warm autoimmune hemolytic anemia has not responded to other treatments.
- Who it's for
- Adults who have ITP or warm autoimmune hemolytic anemia that has not improved with standard care.
- What's involved
- Participants will receive increasing doses of CTX112 and will have regular blood tests and clinic visits to monitor safety and any changes in their disease.
- Time commitment
- The study lasts about 6 months, with several clinic visits and blood draws during that time.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- History of primary or secondary immunodeficiency.
- Presence or history of certain bacterial, viral or fungal infection
See the full eligibility 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)
- 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
- 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.
- History or current diagnosis that requires uninterrupted, ongoing anticoagulation.
- Pregnant or lactating.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- Cologne, Germany
- Dresden, Germany
- Hanover, Germany
- Mainz, Germany
- Barcelona, Spain
- Córdoba, Spain
- Madrid, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States; Rochester, Minnesota, United States; Omaha, Nebraska, United States; Cologne, Germany; Dresden, Germany; Hanover, Germany and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.