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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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).

What is being tested

Sponsor: CRISPR Therapeutics AG · Participants: 60 · Started: Jul 17, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07549698

Locations in the U.S.

MinnesotaMayo Clinic in Rochester, Rochester
NebraskaUniversity of Nebraska Medical Center, Omaha

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.