AsthmaPhase 1MGH-002NCT01711593
Induced Tolerogenic Dendritic Cells as Modulators of Allergic Asthma
A Phase 1 study testing Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage and Phlebotomy in people with Asthma and Allergies, run by Andrew D. Luster, M.D.,Ph.D. at 1 site in United States.
Trial summary
Despite advances in medications, allergic diseases, including allergic asthma continue to rise in prevalence. For this reason, there is a need for a better understanding of the mechanisms of allergic diseases and novel insights into modulating allergic inflammation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage and Phlebotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with Allergic Asthma (AA subjects):
- All subjects will have a baseline FEV1 no less than 75 % of the predicted value after bronchodilator administration.
- All subjects will have both a clinical history of allergic symptoms to cat or dust mite allergen and a positive allergen prick test (3 mm diameter greater than diluent control)
- Life-long absence of cigarette smoking (lifetime total of < 5 pack-years and none in 5 years).
- Willing and able to give informed consent.
- Expressed the desire to participate in an interview with the principal investigator.
Show all 11Show fewer
- Age between 18 and 50 years.
- A methacholine PC20 < 16 mg/ml.
- Asthma of severity defined as: requiring no more than step 3 therapy (NHLBI Guidelines, 2007), well-controlled and having a validated asthma control test (ACT) score of > 19 for one month prior to the screening visit, and able to tolerate a 2 week stoppage of inhaled corticosteroids prior to Visit 2.
- Healthy Control Subjects (HC subjects):
- Normal control subjects will be individuals who are in good overall health, age and sex matched to the asthmatic group, age 18 - 50 and nonallergic, i.e. entirely negative on the panel of prick skin tests with no history of allergic rhinitis or asthma, no history of allergic symptoms caused by cats or dust mite allergen exposure, life-long nonsmokers of cigarettes (defined as a lifetime total of less than 5 pack-years and none in 5 years), normal spirometry (i.e. FEV1 and FVC of at least 90% of predicted) and with a methacholine PC20 of > 16 mg/ml.
Who cannot join
- Subjects with Allergic Asthma (AA subjects):
- Women of childbearing potential who are pregnant (based on urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant, or who are nursing.
- The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.
- Participation in a research study involving a drug or biologic during the 30 days prior to the study.
- Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
- Antihistamines within 7 days of the screening visit.
Show all 24Show fewer
- Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis.
- Use of systemic steroids, increased use of inhaled steroids, beta blockers and MAO inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit.
- Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits.
- A history of asthma-related respiratory failure requiring intubation.
- Quantitative skin-prick test positive reaction down to an allergen concentration of 0.056 BAU or AU/ml.
- Subjects with a high possibility of poor compliance with the study.
- Have a history of cigarette smoking within the past 5 years or > 5 pack years total.
- Having second-hand cigarette smoke exposure or indoor furry pets except in the case of dog, if the subject is not allergic to the dog and the subject has a negative skin test to dog.
- Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection.
- Use of Xolair (omalizumab - anti-IgE monoclonal antibody) for 6 months.
- Immunotherapy with cat or dust mite extract now or in the past.
- Use of prophylactic aspirin for cardiovascular disease.
- Non-English speakers.
- Weight less than 110 pounds
- Hematocrit < 0.36 for females, <0.38 for males.
- Healthy Normal Control Subjects (HC subjects):
- A history of allergy, asthma, nasal or sinus disease.
- Exclusion criteria #1, 3-8 and 10-20 from (A.) above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Despite advances in medications, allergic diseases, including allergic asthma continue to rise in prevalence. For this reason, there is a need for a better understanding of the mechanisms of allergic diseases and novel insights into modulating allergic inflammation. The investigators hypothesize that much remains to be learned about the behavior of T effector and T regulatory cells in allergic disease. Furthermore, the investigators hypothesize that novel mechanisms of allergic tolerance may exist, and elucidation of these mechanisms may provide insights into novel therapeutic strategies to control allergic diseases. The investigators will investigate the capacity for T cell tolerance induction in allergic subjects by a novel type of immune tolerizing dendritic cell (it-DC). The investigators will assess whether in vitro generated it-DCs have the capacity to induce antigen-specific T regulatory cells and suppress allergen-specific T effector cell function in vitro.
Standardized Cat Allergen extract and Dust Mite Allergens will be used to generate changes in the airways that occur during exposure to allergen. For this investigation, the route of administration will be topical application of the titrated allergen to a bronchoscopically isolated subsegment of one lobe of one lung. The dose of biologic will be determined from prior skin-prick testing.
Read the detailed description
This is a single-center, open-label, controlled mechanistic study before-and-after allergen instillation study that uses each subject as his/her own control. Reliability of study measurements of expression is accomplished by comparing repeated measurements. Additional controls are provided by measuring the expression of markers known to have stable expression, including cell structural proteins and chemokine markers that the investigators know are induced in this experimental paradigm from our previous studies. This is an investigational study. Subjects will receive an investigational product, either Standardized Cat Allergen Extract or Standardized Dust Mite Allergen (Dermatophagoides farinae or D. pteronyssinus). No subject will be given a placebo. There are 2 cohorts, allergic asthmatics (AA) and healthy controls (HC). The main comparisons will be measurement of primary and secondary outcome measures in: (1) diluent versus allergen-challenged segments of the lung in each asthmatic subject and (2) comparison of these responses in allergic asthmatics (AA) and healthy controls (HC).
The investigators will enroll 20 AA subjects (10 in Track 1 \& 10 in Track 2) and 10 HC subjects (Track 1). There will be no randomization. The choice of allergen will be determined by allergy skin testing. When a subject is allergic to both cat and dust mite, one will be selected with a goal of having a representative sample of cat and dust mite challenges in each cohort. The 10 allergic asthmatic (AA) subjects and HC subjects in Track 1 will undergo preliminary screening tests and provide 200 ml of blood for DC and T cell studies on one occasion. Track 1 subjects will not undergo bronchoscopy, bronchoalveolar lavage, or segmental allergen challenge. The 10 allergic asthmatic (AA) subjects in Track 2 will undergo SAC with either standardized cat or mite allergen. These subjects will also donate 200 ml of blood on two occasions separated by a minimum of 4 weeks and not more than 12 weeks.
- Being tested
- Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage, Phlebotomy
- Keywords
- Asthma, Allergic, Inflammation, Airway, Challenge, Chemokines, Tolerization
- Medical subject headings
- Asthma, Hypersensitivity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar LavageBiological
Also called One of 3 Standardized allergen extracts will be used:, 1)Cat hair, 2)Dust Mite Dermatophagoides farinae, 3)Dust Mite Dermatophagoides pteronyssinus
On the first bronchoscopy day,BAL will first be performed in the lingual without instillation of diluent or allergen. A 2ml aliquot of isotonic diluent is instilled into the right upper lobe.The procedure is repeated in the right middle lobe with instillation of 2ml of standardized cat or mite allergen solution. A test dose concentration of allergen is administered first consisting of 2 ml of allergen at 1/10th(Cat,D.farinae)or 1/30th(D.pteronyssinus)the threshold concentration.If on visual inspection through the bronchoscope there is no evidence of mucosal inflammation after 2 minutes a second segmental allergen challenge will be done in the right middle lobe using 2ml of full-dose allergen at the threshold concentration(Cat,D.farinae)or 1/3 the threshold concentration(D.pteronyssinus). This dose will be predetermined by quantitative skin prick testing.A second bronchoscopy is performed 24 hours after delivery of allergen extract and diluent to obtain BAL fluid from the RUL and RML.
PhlebotomyProcedure or surgery
Also called Blood Draw
200 (40 teaspoons) ml of blood will be obtained from the subjects to collect different leukocyte populations. A second 200 ml of blood will be obtained from the Track 2 subjects 4 weeks later for isolation of T lymphocytes for functional studies.
| Study group | Role | What they receive |
|---|---|---|
| Allergic Asthmatic, Non-allergic non-asthmatics(HC) | Experimental | Track 1: Adult subjects who are allergic asthmatics or non-allergic non-asthmatics(Healthy Controls) will not receive segmental allergen challenge to the lung but will have their blood drawn at 1 time point. Track 2: Adult subjects who are allergic asthmatics will receive segmental allergen challenge to the lung and have their blood drawn at 2 time points. Receives: Biological: Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage; Procedure: Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of it-DC on the phenotype, function, proliferation and survival of allergen-specific effector T cells.
We will generate induced tolerogenic dendritic cells (it-DCs) in vitro from peripheral blood monocytes and dendritic cells isolated from each allergic asthmatic subject and assess their capacity to (a) attenuate effector CD4+ T cell (Teff) responses and/or (b) induce T regulatory (Treg) cells from Teff cells as well as CD4+ naïve and memory T cells. Attenuation of T cell responses (a) will be assessed by proliferation assays and cytokine production. Moreover, in order to evaluate the functionality of the it-DC induced Tregs (b), co-culture suppression assays using cat or house dust-mite allergen-specific Teff cells isolated from BAL following segmental allergen challenge (SAC) as responder cells, will be examined. The percent suppression of responding Teff cells will be assessed by examining Teff cell proliferation and survival/apoptosis, and by cytokine production.
(Note: SAC samples from healthy controls are not involved in the primary analysis.)
Measured: 24 hours
Secondary outcomes (3)
Percent distribution of peripheral blood DC subsets
We will determine the frequency of each peripheral blood DC subset from allergic asthmatic subjects at 0 and 4 weeks using cell surface staining/flow cytometry analysis. Results will be expressed in terms of percent distribution of each DC subset within the total DC pool.
Measured: 4 weeks
Percent suppression of naïve T cells (Tn) and memory T cells (Tmem) proliferation by it-DC-induced Tregs from each subject.
The ability of it-DC-induced Tregs from each allergic asthmatic to suppress proliferation of autologous CD4+ Tn and Tmem cells in response to anti-CD3 will be assessed and expressed as a percent suppression of proliferation using an in vitro proliferation assay.
Measured: 4 weeks
Differences in proliferation by allergen-specific Teff cells from BAL and blood.
We will measure the proliferative responses in it-DC co-culture assays by allergen-specific CD4+ Teff cells obtained from the BAL of allergic asthmatic subjects as compared to those of blood-derived CD4+ Tmem cells from the same subjects and from 10 healthy controls.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew D. Luster, M.D.,Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew D. Luster, M.D.,Ph.D., Massachusetts General Hospital
- Investigators
- Andrew D Luster, M.D., Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711593
- Sponsor's protocol ID
- 2012P0001076
- Other IDs
- 1U19AI095261
- Acronym
- MGH-002
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2012
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Tolerogenic Dendritic Cells as Modulators of Allergic Asthma
- ClinicalTrials.gov ID
- NCT01711593
- Acronym / sponsor ID
- MGH-002 / 2012P0001076
- Keywords
- Asthma, Allergic, Inflammation, Airway, Challenge, Chemokines, Tolerization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Andrew D. Luster, M.D.,Ph.D.University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Oct 2012 (estimated)
- 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.
Despite advances in medications, allergic diseases, including allergic asthma continue to rise in prevalence. For this reason, there is a need for a better understanding of the mechanisms of allergic diseases and novel insights into modulating allergic inflammation. The investigators hypothesize that much remains to be learned about the behavior of T effector and T regulatory cells in allergic disease. Furthermore, the investigators hypothesize that novel mechanisms of allergic tolerance may exist, and elucidation of these mechanisms may provide insights into novel therapeutic strategies to control allergic diseases. The investigators will investigate the capacity for T cell tolerance induction in allergic subjects by a novel type of immune tolerizing dendritic cell (it-DC). The investigators will assess whether in vitro generated it-DCs have the capacity to induce antigen-specific T regulatory cells and suppress allergen-specific T effector cell function in vitro.
Standardized Cat Allergen extract and Dust Mite Allergens will be used to generate changes in the airways that occur during exposure to allergen. For this investigation, the route of administration will be topical application of the titrated allergen to a bronchoscopically isolated subsegment of one lobe of one lung. The dose of biologic will be determined from prior skin-prick testing.
Detailed description
This is a single-center, open-label, controlled mechanistic study before-and-after allergen instillation study that uses each subject as his/her own control. Reliability of study measurements of expression is accomplished by comparing repeated measurements. Additional controls are provided by measuring the expression of markers known to have stable expression, including cell structural proteins and chemokine markers that the investigators know are induced in this experimental paradigm from our previous studies. This is an investigational study. Subjects will receive an investigational product, either Standardized Cat Allergen Extract or Standardized Dust Mite Allergen (Dermatophagoides farinae or D. pteronyssinus). No subject will be given a placebo. There are 2 cohorts, allergic asthmatics (AA) and healthy controls (HC). The main comparisons will be measurement of primary and secondary outcome measures in: (1) diluent versus allergen-challenged segments of the lung in each asthmatic subject and (2) comparison of these responses in allergic asthmatics (AA) and healthy controls (HC).
The investigators will enroll 20 AA subjects (10 in Track 1 \& 10 in Track 2) and 10 HC subjects (Track 1). There will be no randomization. The choice of allergen will be determined by allergy skin testing. When a subject is allergic to both cat and dust mite, one will be selected with a goal of having a representative sample of cat and dust mite challenges in each cohort. The 10 allergic asthmatic (AA) subjects and HC subjects in Track 1 will undergo preliminary screening tests and provide 200 ml of blood for DC and T cell studies on one occasion. Track 1 subjects will not undergo bronchoscopy, bronchoalveolar lavage, or segmental allergen challenge. The 10 allergic asthmatic (AA) subjects in Track 2 will undergo SAC with either standardized cat or mite allergen. These subjects will also donate 200 ml of blood on two occasions separated by a minimum of 4 weeks and not more than 12 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergic Asthmatic, Non-allergic non-asthmatics(HC) | Experimental | Biological: Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage, Procedure: PhlebotomyTrack 1: Adult subjects who are allergic asthmatics or non-allergic non-asthmatics(Healthy Controls) will not receive segmental allergen challenge to the lung but will have their blood drawn at 1 time point. Track 2: Adult subjects who are allergic asthmatics will receive segmental allergen challenge to the lung and have their blood drawn at 2 time points. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- All subjects will have a baseline FEV1 no less than 75 % of the predicted value after bronchodilator administration.
- All subjects will have both a clinical history of allergic symptoms to cat or dust mite allergen and a positive allergen prick test (3 mm diameter greater than diluent control)
- Life-long absence of cigarette smoking (lifetime total of < 5 pack-years and none in 5 years).
- Willing and able to give informed consent.
- Expressed the desire to participate in an interview with the principal investigator.
Key exclusion criteria (24 listed)
- Women of childbearing potential who are pregnant (based on urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant, or who are nursing.
- The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.
- Participation in a research study involving a drug or biologic during the 30 days prior to the study.
- Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
- Antihistamines within 7 days of the screening visit.
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 |
|---|---|---|
| Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar LavageAlso: One of 3 Standardized allergen extracts will be used:, 1)Cat hair, 2)Dust Mite Dermatophagoides farinae, 3)Dust Mite Dermatophagoides pteronyssinusOn the first bronchoscopy day,BAL will first be performed in the lingual without instillation of diluent or allergen. A 2ml aliquot of isotonic diluent is instilled into the right upper lobe.The procedure is repeated in the right middle lobe with instillation of 2ml of standardized cat or mite allergen solution. A test dose concentration of allergen is administered first consisting of 2 ml of allergen at 1/10th(Cat,D.farinae)or 1/30th(D.pteronyssinus)the threshold concentration.If on visual inspection through the bronchoscope there is no evidence of mucosal inflammation after 2 minutes a second segmental allergen challenge will be done in the right middle lobe using 2ml of full-dose allergen at the threshold concentration(Cat,D.farinae)or 1/3 the threshold concentration(D.pteronyssinus). This dose will be predetermined by quantitative skin prick testing.A second bronchoscopy is performed 24 hours after delivery of allergen extract and diluent to obtain BAL fluid from the RUL and RML. | Biological | Allergic Asthmatic, Non-allergic non-asthmatics(HC) |
| PhlebotomyAlso: Blood Draw200 (40 teaspoons) ml of blood will be obtained from the subjects to collect different leukocyte populations. A second 200 ml of blood will be obtained from the Track 2 subjects 4 weeks later for isolation of T lymphocytes for functional studies. | Procedure or surgery | Allergic Asthmatic, Non-allergic non-asthmatics(HC) |
Primary outcome
Effect of it-DC on the phenotype, function, proliferation and survival of allergen-specific effector T cells.
Time frame: 24 hours
We will generate induced tolerogenic dendritic cells (it-DCs) in vitro from peripheral blood monocytes and dendritic cells isolated from each allergic asthmatic subject and assess their capacity to (a) attenuate effector CD4+ T cell (Teff) responses and/or (b) induce T regulatory (Treg) cells from Teff cells as well as CD4+ naïve and memory T cells. Attenuation of T cell responses (a) will be assessed by proliferation assays and cytokine production. Moreover, in order to evaluate the functionality of the it-DC induced Tregs (b), co-culture suppression assays using cat or house dust-mite allergen-specific Teff cells isolated from BAL following segmental allergen challenge (SAC) as responder cells, will be examined. The percent suppression of responding Teff cells will be assessed by examining Teff cell proliferation and survival/apoptosis, and by cytokine production. (Note: SAC samples from healthy controls are not involved in the primary analysis.)
3 secondary outcomes
Percent distribution of peripheral blood DC subsets
Time frame: 4 weeks
Percent suppression of naïve T cells (Tn) and memory T cells (Tmem) proliferation by it-DC-induced Tregs from each subject.
Time frame: 4 weeks
Differences in proliferation by allergen-specific Teff cells from BAL and blood.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 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.
Andrew D Luster, M.D., Ph.D. principal investigator
Massachusetts General Hospital
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 Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage and Phlebotomy in people with Asthma and Allergies, run by Andrew D. Luster, M.D.,Ph.D. at 1 site in United States.
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 11 inclusion and 24 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: finished, as of the sponsor's last update on 28 Sep 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of it-DC on the phenotype, function, proliferation and survival of allergen-specific effector T cells. (time frame: 24 hours). 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 28 Sep 2026.