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CTX112

Phase 1

Warm Autoimmune Hemolytic Anemia (WAIHA) | Monoclonal antibody | Hematology |CRISPR Therapeutics AG|Last Updated: Jul 22, 2026

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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
RMAT
Clinical trial landscape

CTX112 · 3 trials · 19 indications

Phase 1 3
NCT07549698Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune DiseaseWarm Autoimmune Hemolytic Anemia (WAIHA)
RECRUITING60 Analytics
NCT06925542A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune DiseaseSLE (Systemic Lupus)
RECRUITING80 Analytics
NCT05643742A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell MalignanciesB-cell Lymphoma
RECRUITING120 Analytics
PHASE1RECRUITING
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Warm Autoimmune Hemolytic Anemia (WAIHA)
NCT0754969860
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PHASE1RECRUITING
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
SLE (Systemic Lupus)
NCT0692554280
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PHASE1RECRUITING
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
B-cell Lymphoma
NCT05643742120
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Study Endpoints
Primary Endpoints
To evaluate the safety of CTX112 in adult participants with refractory hematologic autoimmune diseases, including ITP or wAIHA.
From CTX112 infusion up to 28 days post infusion.

Incidence of dose-limiting toxicities.

To evaluate the safety of CTX112 in adult subjects with refractory autoimmune diseases, including SLE, SSc or IIM
From CTX112 infusion up to 28 days post-infusion

Incidence of dose-limiting toxicities

Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
From CTX112 infusion up to 28 days post-infusion
Phase 2 (Cohort Expansion): Objective response rate
From CTX112 infusion up to 60 months post-infusion
Secondary Endpoints
To assess the pharmacodynamics response to CTX112 in adult participants with ITP or wAIHA.
From CTX112 infusion up to 60 months post-infusion
To assess the pharmacokinetics (PK) of CTX112 in adult participants with ITP or wAIHA.
From CTX112 infusion up to 60 months post-infusion.
To assess the preliminary efficacy of CTX112 in adult participants with ITP or wAIHA.
From CTX112 infusion up to 60 months post-infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CTX112 (zugo-cel)EXPERIMENTALAdministered by IV infusion following lymphodepleting chemotherapy
CTX112EXPERIMENTALAdministered by IV infusion following lymphodepleting chemotherapy
Interventions
NameTypeDescription
CTX112BIOLOGICALCTX112 (zugo-cel): CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United StatesGermanySpainAustralia
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Recent Changes (Last 90 Days)
LOWJul 22, 2026NCT07549698lastUpdatePostDate: changed
LOWJul 22, 2026NCT06925542lastUpdatePostDate: changed
LOWJul 22, 2026NCT07549698lastUpdatePostDate: changed
LOWJul 22, 2026NCT06925542lastUpdatePostDate: changed
LOWJul 17, 2026NCT07549698lastUpdatePostDate: changed
LOWJul 17, 2026NCT07549698lastUpdatePostDate: changed
LOWJul 17, 2026NCT07549698lastUpdatePostDate: changed
LOWJun 16, 2026NCT07549698Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT06925542lastUpdatePostDate: changed
LOWJun 16, 2026NCT07549698Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT06925542lastUpdatePostDate: changed
LOWJun 16, 2026NCT07549698Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT06925542lastUpdatePostDate: changed
LOWJun 16, 2026NCT07549698Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT06925542lastUpdatePostDate: changed
LOWMay 26, 2026NCT05643742primaryCompletionDate: changed
LOWMay 26, 2026NCT06925542primaryCompletionDate: changed
LOWMay 26, 2026NCT07549698primaryCompletionDate: changed
LOWMay 24, 2026NCT05643742studyFirstPostDate: changed
LOWMay 24, 2026NCT06925542studyFirstPostDate: changed