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CTX112

Phase 1

B-cell Lymphoma | Monoclonal antibody | Oncology |CRISPR Therapeutics AG|Last Updated: Sep 4, 2026

Target and mechanism

Molecular targetCD19
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment120

FDA Designations

RMAT

Clinical trial landscape

CTX112 · 4 trials · 24 indications

Phase 1 4
NCT07804004A Safety and Efficacy Study Evaluating CTX112 in Subjects With Refractory Neurologic Autoimmune DiseaseProgressive Multiple Sclerosis (PMS)
NOT YET_RECRUITING220 Analytics
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
PHASE1NOT YET_RECRUITING
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Refractory Neurologic Autoimmune Disease
Progressive Multiple Sclerosis (PMS)Unlock trial analytics
PHASE1RECRUITING
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Warm Autoimmune Hemolytic Anemia (WAIHA)Unlock trial analytics
PHASE1RECRUITING
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
SLE (Systemic Lupus)Unlock trial analytics
PHASE1RECRUITING
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
B-cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety of CTX112 in adult participants with neurological autoimmue disorders, including PMS, relapsing NMOSD, relapsing MOGAD, refractory AIE, and refractory SPS.
From CTX112 infusion up to 28 days post infusion

Incidence of dose-limiting toxicities.

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 adults with neurological autoimmune disorders
From CTX112 infusion up to 24 months post-infusion
To assess the pharmacokinetics (PK) of CTX112 in adults with neurological autoimmune disorders.
From CTX112 infusion up to 24 months post-infusion.
To assess the preliminary efficacy of CTX112 in adults with PMS.
From CTX112 infusion up to Month 6, Month 12, Month 18, and Month 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CTX112EXPERIMENTALAdministered by IV infusion following lymphodepleting chemotherapy
CTX112 (zugo-cel)EXPERIMENTALAdministered by IV infusion following lymphodepleting chemotherapy

Interventions

NameTypeDescription
CTX112BIOLOGICALCTX112 is a 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 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Age ≥18 years and \<70 years at screening. 2. Body weight \>40 kg. 3. Participants must voluntarily sign a written informed consent and be willing and able to comply with all trial requirements. Legal authorized representative, additional assent and witness may be used as app...

Countries:United StatesGermanySpainAustralia
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Competitive Landscape -Cutaneous T-Cell Lymphoma 3 trials (matched to "B-cell Lymphoma")

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Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07804004NEW_TRIAL: changed
LOWSep 4, 2026NCT07804004NEW_TRIAL: changed
LOWAug 28, 2026NCT06925542lastUpdatePostDate: changed
LOWAug 28, 2026NCT06925542lastUpdatePostDate: changed
LOWAug 7, 2026NCT06925542lastUpdatePostDate: changed
LOWAug 7, 2026NCT06925542lastUpdatePostDate: changed
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

Frequently asked questions about CTX112

What is CTX112 used for?

CTX112 is an investigational CD19-targeted therapy being studied for B-cell lymphomas and other B-cell malignancies, as well as autoimmune diseases including systemic lupus erythematosus (SLE), warm autoimmune hemolytic anemia (WAIHA), and immune thrombocytopenia (ITP). It is in Phase 1 clinical development for these conditions.

What does CTX112 target?

CTX112 targets CD19, a protein found on the surface of B cells. By targeting CD19, CTX112 is designed to deplete or modify B cells involved in certain cancers and autoimmune diseases. This mechanism is being evaluated in clinical trials for B-cell malignancies and autoimmune conditions.

Who makes CTX112?

CTX112 is being developed by CRISPR Therapeutics AG, a biopharmaceutical company traded on NASDAQ under the ticker CRSP. The company is conducting Phase 1 clinical trials to evaluate the safety and efficacy of CTX112 in patients with B-cell malignancies and autoimmune diseases.

What phase is CTX112 in?

CTX112 is currently in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The drug is being studied in early-stage trials to assess its safety, tolerability, and preliminary efficacy in patients with B-cell cancers and autoimmune diseases.

What clinical trials is CTX112 in?

CTX112 is being evaluated in three Phase 1 trials: NCT05643742 for relapsed or refractory B-cell malignancies, NCT06925542 for refractory autoimmune diseases including SLE, and NCT07549698 for relapsed or refractory hematologic autoimmune diseases such as WAIHA and ITP. All trials are currently recruiting participants.

Is CTX112 the same as other CD19 therapies?

CTX112 is a distinct investigational therapy targeting CD19, developed by CRISPR Therapeutics. It is not the same as other CD19-directed treatments, as it is a specific product candidate with its own clinical development program. No alternative names for CTX112 have been reported.