No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
CRISPR Therapeutics AG · Industry
Who this trial is looking for
This trial is looking for adults with certain blood disorders who have not responded to previous treatments. Participants will receive the treatment CTX112 and will need to follow specific visit and testing schedules.
Are You a Good Fit for This Trial?
Rules you outPrimary immunodeficiencyBone marrow failure genetic disorder
You may be able to join if
I am at least 18 years old.
I can provide written consent and follow trial requirements.
I have been diagnosed with Immune Thrombocytopenia or Warm Autoimmune Hemolytic Anemia.
I have good overall health, including blood and organ function.
I agree to use contraception during the trial.
You may not be able to join if
I have had previous treatment with certain gene therapies.
I have had an organ transplant.
I have a severe history of central nervous system issues.
I have another active autoimmune disease.
I have a history of certain infections.
I have been diagnosed with cancer in the last 5 years (except low-risk cancers).
I am currently pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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City
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Status
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 contra…
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.
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