Recruiting
Phase 1
Phase 2

CTX112

Sponsor:

CRISPR Therapeutics AG

Code:

NCT07549698

Conditions

Warm Autoimmune Hemolytic Anemia (WAIHA)

ITP - Immune Thrombocytopenia

Warm Autoimmune Hemolytic Anemia

Immune Thrombocytopenic Purpura

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CTX112

Study Details

Brief summary:

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).

Conditions

Warm Autoimmune Hemolytic Anemia (WAIHA)

ITP - Immune Thrombocytopenia

Warm Autoimmune Hemolytic Anemia

Immune Thrombocytopenic Purpura

Study ID

NCT07549698

Start date

Jun, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CTX112 (zugo-cel)

Administered by IV infusion following lymphodepleting chemotherapy

Interventions

CTX112

CTX112 (zugo-cel): CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components

Primary outcome measure

  • To evaluate the safety of CTX112 in adult participants with refractory hematologic autoimmune diseases, including ITP or wAIHA. [ Time Frame: From CTX112 infusion up to 28 days post infusion. ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Jithma Abeykoon

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator:

Marcel Devetten

More Information

Sponsor

CRISPR Therapeutics AG

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • CD19
  • CTX112
  • Zugocabtagene geleucel
  • zugo-cel
  • CAR-T
  • ITP
  • warm autoimmune hemolytic anemia
  • wAIHA
  • Immune Thrombocytopenic Purpura
  • Immune Thrombocytopenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CRISPR Therapeutics AG on 2026-07-22.