IgE-Mediated HypersensitivityPhase 1NCT07408869
A Phase 1 Study of Cizutamig in IgE Mediated Diseases
A Phase 1 study testing Cizutamig in people with IgE-Mediated Hypersensitivity and IgE Mediated Food Allergy, run by Candid Therapeutics at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IgE-Mediated Hypersensitivity, IgE Mediated Food Allergy, IgE-Mediated Cow Milk Allergy
- What is being tested?
- Cizutamig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient meets at least one of the following:
- History of documented (skin prick test, in vitro testing, or food challenge), ongoing, IgE-mediated allergy to food (eg, peanut, hazelnut, walnut, cashew, milk, egg/egg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and/or shrimp) with Screening total IgE ≥ 400 IU/mL
- Diagnosis of chronic rhinosinusitis with Screening total IgE > ULN
- Diagnosis of allergic rhinitis with Screening total IgE > ULN
- Diagnosis of asthma and classified as well controlled per 2024 Global Initiative for Asthma guidelines with Screening total IgE > ULN
- Diagnosis of chronic spontaneous urticaria with symptoms (eg, wheals or angioedema) for at least 6 weeks any time prior to screening and Screening total IgE > ULN
- Diagnosis of atopic dermatitis that has been present for at least 6 months before the screening visit and with Screening total IgE > ULN
- Agree to the use of highly effective contraception
Who cannot join
- Elevated IgE levels for reasons other than the IgE mediated diseases
- Planned ingestion of food items to which they are allergic for the duration of the study (for food allergy patients)
- Current use of any allergen immunotherapy.
- Individuals whose allergen exposures in their home and/or work environments may be expected to change significantly during the trial period
- Inadequate clinical laboratory parameters at Screening
- Receipt of or inability to discontinue any excluded therapies
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- Individuals who will decline blood products
- Active infection
- Serious mental illness, drug or alcohol abuse, dementia, or other condition that impair ability to sign ICF
- Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)
- History of primary immunodeficiency
- History of CNS disease
- History of poorly controlled diabetes, chronic kidney disease, chronic pulmonary disease, uncontrolled cardiovascular disease, history of malignancy within 5 years
- History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug
- Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period
- Blood donation or significant blood loss within 30 days prior to screening
- Individuals considered to be part of a vulnerable population (eg, incarceration)
- Individuals that in the opinion of the Investigator, are not suitable for participation in the trial
- Inability to comply with protocol-mandated requirements
- A history of severe allergic or anaphylactic reactions related to the underlying IgE mediated disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Open-Label Study Evaluating the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Cizutamig in IgE Mediated Diseases
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
Read the detailed description
This is a Phase 1b, open-label study evaluating the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
- Being tested
- Cizutamig
- Keywords
- peanut allergy, nut allergy, hazelnut allergy, walnut allergy, cashew allergy, milk allergy, egg allergy, soy allergy, wheat allergy, sesame allergy, cod allergy, salmon allergy, tuna allergy, lobster allergy, crab allergy, shrimp allergy, food allergy, rhinosinusitis, allergic rhinitis, asthma
- Medical subject headings
- Hypersensitivity, Immediate, Food Hypersensitivity, Peanut Hypersensitivity, Nut Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity, Wheat Hypersensitivity, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CizutamigBiological
cizutamig will be dosed SC according to the assigned cohort
| Study group | Role | What they receive |
|---|---|---|
| cizutamig (single dose) | Experimental | cizutamig will be dosed subcutaneously according to the cohort assignment Receives: Biological: Cizutamig |
| cizutamig (multiple dose) | Experimental | cizutamig will be dosed subcutaneously according to the cohort assignment Receives: Biological: Cizutamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ability of cizutamig to reduce IgE levels
Change from baseline in serum IgE
Measured: Baseline to Week 12
Secondary outcomes (26)
Incidence and severity of treatment-emergent adverse events through end of study
Measured: Baseline to Week 24
PK parameters: Cmax
Measured: Baseline to 24 Weeks
PK parameters: Tmax
Measured: Baseline to Week 24
PK parameters: AUC
Measured: Baseline to 24 Weeks
PK Parameter: CL
Measured: Baseline to 24 Weeks
PK Parameters: Vd
Measured: Baseline to 24 Weeks
PK Parameters: t1/2
Measured: Baseline to 24 Weeks
Anti-drug antibodies (ADAs)
Measured: Baseline to 24 Weeks
Changes in body temperature
Measured: Baseline to 24 Weeks
Changes to blood pressure
systolic and diastolic
Measured: Baseline to 24 Weeks
Changes in heart rate
Measured: Baseline to 24 Weeks
Changes to respiratory rate
Measured: Baseline to 24 Weeks
Changes to pulse oximetry
Measured: Baseline to 24 Weeks
Changes in ECG parameters: QRS interval
Measured: Baseline to 24 Weeks
Changes in ECG parameters: PR interval
Measured: Baseline to 24 Weeks
Changes in ECG parameters: QTcB
Measured: Baseline to 24 Weeks
Changes in ECG parameters: QTcF
Measured: Baseline to 24 Weeks
Changes in ECG parameters: QT interval
Measured: Baseline to 24 Weeks
Changes in ECG parameters: RR
Measured: Baseline to 24 Weeks
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Measured: Baseline to 24 Weeks
Changes from baseline in Red Blood Cell count
Measured: Baseline to 24 Weeks
Changes from baseline in White Blood Cell count
Measured: Baseline to 24 Weeks
Changes from baseline in Platelets
Measured: Baseline to 24 Weeks
Changes from baseline in Hematocrit
Measured: Baseline to 24 Weeks
Changes from baseline in Hemoglobin
Measured: Baseline to 24 Weeks
Frequency and percentage of anti-drug antibodies (ADAs)
Measured: Baseline to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgE-Mediated HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408869
- Sponsor's protocol ID
- CND106-110
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label Study Evaluating the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Cizutamig in IgE Mediated Diseases
- ClinicalTrials.gov ID
- NCT07408869
- Acronym / sponsor ID
- CND106-110
- Keywords
- peanut allergy, nut allergy, hazelnut allergy, walnut allergy, cashew allergy, milk allergy, egg allergy, soy allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Candid TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
Detailed description
This is a Phase 1b, open-label study evaluating the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cizutamig (single dose) | Experimental | Biological: Cizutamigcizutamig will be dosed subcutaneously according to the cohort assignment |
| cizutamig (multiple dose) | Experimental | Biological: Cizutamigcizutamig will be dosed subcutaneously according to the cohort assignment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient meets at least one of the following:
- Agree to the use of highly effective contraception
Key exclusion criteria (20 listed)
- Elevated IgE levels for reasons other than the IgE mediated diseases
- Planned ingestion of food items to which they are allergic for the duration of the study (for food allergy patients)
- Current use of any allergen immunotherapy.
- Individuals whose allergen exposures in their home and/or work environments may be expected to change significantly during the trial period
- Inadequate clinical laboratory parameters at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cizutamigcizutamig will be dosed SC according to the assigned cohort | Biological | cizutamig (multiple dose), cizutamig (single dose) |
Primary outcome
To evaluate the ability of cizutamig to reduce IgE levels
Time frame: Baseline to Week 12
Change from baseline in serum IgE
26 secondary outcomes
Incidence and severity of treatment-emergent adverse events through end of study
Time frame: Baseline to Week 24
PK parameters: Cmax
Time frame: Baseline to 24 Weeks
PK parameters: Tmax
Time frame: Baseline to Week 24
PK parameters: AUC
Time frame: Baseline to 24 Weeks
PK Parameter: CL
Time frame: Baseline to 24 Weeks
PK Parameters: Vd
Time frame: Baseline to 24 Weeks
PK Parameters: t1/2
Time frame: Baseline to 24 Weeks
Anti-drug antibodies (ADAs)
Time frame: Baseline to 24 Weeks
Changes in body temperature
Time frame: Baseline to 24 Weeks
Changes to blood pressure
Time frame: Baseline to 24 Weeks
Changes in heart rate
Time frame: Baseline to 24 Weeks
Changes to respiratory rate
Time frame: Baseline to 24 Weeks
Changes to pulse oximetry
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: QRS interval
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: PR interval
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: QTcB
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: QTcF
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: QT interval
Time frame: Baseline to 24 Weeks
Changes in ECG parameters: RR
Time frame: Baseline to 24 Weeks
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time frame: Baseline to 24 Weeks
Changes from baseline in Red Blood Cell count
Time frame: Baseline to 24 Weeks
Changes from baseline in White Blood Cell count
Time frame: Baseline to 24 Weeks
Changes from baseline in Platelets
Time frame: Baseline to 24 Weeks
Changes from baseline in Hematocrit
Time frame: Baseline to 24 Weeks
Changes from baseline in Hemoglobin
Time frame: Baseline to 24 Weeks
Frequency and percentage of anti-drug antibodies (ADAs)
Time frame: Baseline to 24 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cizutamig in people with IgE-Mediated Hypersensitivity and IgE Mediated Food Allergy, run by Candid Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the ability of cizutamig to reduce IgE levels (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.