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CTX112

Phase 1

Warm Autoimmune Hemolytic Anemia (WAIHA) | Monoclonal antibody | Hematology |CRISPR Therapeutics AG|Last Updated: Apr 24, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
RMAT
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07549698Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune DiseasePHASE1 NOT YET_RECRUITING 60 — — Apr 1, 2026Dec 1, 2033Apr 24, 2026 - —
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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.

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
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 — N/A
SexALL
Healthy VolunteersNo

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...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07549698primaryCompletionDate: changed
LOWMay 24, 2026NCT07549698studyFirstPostDate: changed
LOWMay 21, 2026NCT07549698NEW_TRIAL: changed
LOWMay 21, 2026NCT07549698NEW_TRIAL: changed