Idiopathic Pulmonary Fibrosis(IPF)Phase 1NCT07329959
CAR-DC for End-Stage IPF
A Phase 1 study testing Leukapheresis and CAR-DC in people with Idiopathic Pulmonary Fibrosis(IPF), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fatal interstitial lung disease characterized by irreversible scarring, leading to respiratory failure. With limited treatment options and a poor prognosis, new therapies are urgently needed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis(IPF)
- What is being tested?
- Leukapheresis and CAR-DC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 28 Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged between 18 and 75 years, inclusive, with a diagnosis of idiopathic pulmonary fibrosis (IPF).
- 2. Ability to verbally confirm understanding of the risks, benefits, and alternative treatments associated with immunosuppressive CAR-DC therapy. Provision of written informed consent by the patient or their legally authorized representative prior to participation.
- 3. Evidence of disease progression (worsening pulmonary fibrosis and declining lung function) despite treatment with standard therapies such as pirfenidone, nintedanib, or other appropriate regimens.
- 4. Meets at least one criterion indicating eligibility for lung transplantation due to interstitial lung disease, while not consenting to a transplant. The criteria include:
- A decline in forced vital capacity (FVC) ≥10% over a 6-month follow-up period.
- A decline in diffusing capacity of the lungs for carbon monoxide (DLCO) ≥10% of predicted value over 6 months.
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- Six-minute walk test results showing oxygen saturation <88%, a distance walked <250 meters, or a decline of >50 meters in distance over 6 months.
- Presence of pulmonary hypertension (PH) confirmed by right heart catheterization or transthoracic echocardiography.
- Hospitalization due to respiratory functional decline, pneumothorax, or acute exacerbation.
- 5. No prior cellular immunotherapy within the last 3 months. 6. Hematological parameters meeting the following thresholds: hematocrit >30%, lymphocyte count >0.5 × 10⁹/L, and platelet count >60 × 10⁹/L.
Who cannot join
- History of acute exacerbation of IPF within 4 weeks prior to screening or during the screening period.
- Presence of interstitial lung disease (ILD) other than IPF, including but not limited to: other forms of idiopathic interstitial pneumonia; ILD associated with fibrogenic agents, environmental exposures, or drug toxicity; other occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; or ILD related to systemic diseases (e.g., vasculitis, infections such as tuberculosis, connective tissue diseases). Cases with uncertain diagnosis require serological testing and/or multidisciplinary team review for confirmation.
- Presence of significant active infection.
- History of malignancy, except for malignancies treated with curative intent and with no recurrence for ≥5 years, resected basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix, or resected colonic polyps.
- Significant history of infectious diseases.
- Presence of psychiatric illness or other conditions that would compromise the patient's ability to cooperate with study requirements, comply with treatment, or undergo monitoring.
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- Known hypersensitivity to any component of the immunosuppressive CAR-DC cell product.
- History of severe renal failure requiring renal dialysis, or serum creatinine level >2.5 mg/dL.
- Any contraindication to the investigational product or study procedures.
- Pregnancy or lactation.
- History of pulmonary embolism (PE), deep vein thrombosis (DVT), or recurrent thromboembolic events.
- Uncorrected thrombocytopenia (platelet count <50,000/μL) or systemic coagulopathy (INR >2.5 or aPTT >2.5 times the control value in the absence of anticoagulant therapy), or active bleeding with uncorrectable coagulopathy.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels >5.0 times the upper limit of normal (ULN), or total bilirubin >3 mg/dL.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fatal interstitial lung disease characterized by irreversible scarring, leading to respiratory failure. With limited treatment options and a poor prognosis, new therapies are urgently needed. This study investigates a novel cell therapy targeting pathological fibroblasts, a key driver of fibrosis.
Single-cell analyses identify CTHRC1+FAP+ fibroblasts as a collagen-producing subpopulation crucial in IPF progression. Chimeric antigen receptor (CAR) technology enables precise targeting of these cells. While CAR-Treg therapy has shown promise in preclinical models, its clinical translation requires careful safety evaluation regarding infection risk, potential tumor promotion, and immune reconstitution.
Read more
This trial employs an innovative approach using engineered dendritic cells (DCs). CAR technology is applied to generate immunosuppressive CAR-DCs (iCAR-DCs) designed to target FAP, localize to fibrotic lung areas, and attenuate fibrosis without eliciting a detrimental immune response. Preliminary mouse studies demonstrated that iCAR-DC administration following lung injury significantly reduced fibrosis without apparent organ toxicity and improved survival.
This single-arm trial aims to evaluate the efficacy and safety of this immunosuppressive CAR-DC therapy in patients with end-stage IPF. Key assessments will include changes in lung function, fibrosis extent on imaging, and comprehensive monitoring of potential adverse effects, particularly infections, tumor markers, and immune parameters.
- Conditions
- Idiopathic Pulmonary Fibrosis(IPF)
- Being tested
- Leukapheresis, CAR-DC
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeukapheresisProcedure or surgery
Subjects will be hospitalized in the Lung Transplant Ward to undergo leukapheresis, followed by an observation period. Eligible subjects, after signing the specific leukapheresis consent form, will undergo apheresis for the collection of approximately 100 ml of blood using a blood cell separator for the preparation of CAR-DC reagents.
CAR-DCBiological
Subjects will be hospitalized to receive autologous FAP-targeted immunosuppressive CAR-DC cell therapy, followed by an observation period. Based on our team's preclinical studies, the starting dose was determined to be 4×10⁵ cells/kg. This trial will employ a standard "3+3" dose-escalation design: Dose Level -1 at 1×10⁵ cells/kg, Dose Level 1 (starting dose) at 4×10⁵ cells/kg, and Dose Level 2 at 8×10⁵ cells/kg.
The 3+3 dose escalation begins with the Dose Level 1 administered to a cohort of three subjects. If no dose-limiting toxicities (DLTs) are observed, the dose is escalated for the next cohort. If one DLT occurs, the cohort is expanded to six subjects at the same dose; escalation proceeds only if no further DLTs are seen in the expanded cohort. If two or more DLTs occur at any point within a cohort, dose escalation stops, and the maximum tolerated dose (MTD) is defined as the highest dose level with an observed DLT rate of less than 2 out of 6 subjects.
| Study group | Role | What they receive |
|---|---|---|
| CAR-DC Treatment | Experimental | Subjects aged 18-75 with end-stage IPF meeting eligibility criteria will be enrolled. The study comprises:
1. Screening: Post-Informed Consent Form (ICF) signing, subjects are screened for eligibility. Only qualified subjects proceed.
2. Leukapheresis: Hospitalized subjects undergo ~100 ml blood collection via apheresis. Valid infectious disease testing is required.
3. Treatment: Hospitalized subjects receive a single infusion of autologous FAP-targeted iCDC cells. Pre-infusion criteria must be met (e.g., no significant infection, creatinine <2×ULN).
4. Post-Treatment Evaluation: Outpatient visits at Months 1, 3, and 6 post-infusion (Day 0). Assessments include pulmonary function tests, chest CT, 6-minute walk test, physical exams, vital signs, lab tests, and peripheral blood monitoring for iCDC cells.
5. Long-Term Follow-Up: For overall survival and long-term safety monitoring. Receives: Procedure: Leukapheresis; Biological: CAR-DC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and efficacy of targeted FAP immunosuppressive CAR-DC in the treatment of end-stage idiopathic pulmonary fibrosis
The incidence of dose-limiting toxicity (DLT) and treatment-related adverse events (TEAE) within 14 days was evaluated in the targeted FAP immunosuppressive CAR-DC therapy for end-stage idiopathic pulmonary fibrosis.
Measured: Within six months after CAR-DC therapy
Secondary outcomes (14)
The difference in forced vital capacity compared to the baseline before treatment
Measured: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The difference in pulmonary carbon monoxide diffusion capacity compared to the baseline before treatment
Measured: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The difference between the ratio of forced expiratory volume in the first second and forced vital capacity compared to the baseline before treatment
Measured: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The difference between the 6-minute walk test result and the baseline value before treatment
Measured: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The difference in the rate of change of pulmonary fibrosis area compared to the baseline before treatment as measured by quantitative CT
Measured: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The total score of the St. George's Respiratory Questionnaire compared to the baseline before treatment
Measured: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The total score of the MRC Questionnaire compared to the baseline before treatment.
Measured: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The times of the acute exacerbation of IPF
Measured: Within six months after CAR-DC therapy
Number of participants with a set of laboratory tests
Blood biochemistry, commonly referred to as clinical chemistry or serum chemistry, is a foundational set of laboratory tests that quantitatively measures key chemical substances within the blood. It provides a vital snapshot of the body's metabolic state and the functional health of major organ systems.
Measured: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
Complete Blood Count
A complete blood count (CBC), often referred to as hematology in a clinical lab context, is one of the most fundamental and frequently ordered blood tests. It provides a quantitative and qualitative analysis of the cellular components of the blood.
Measured: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
Lymphocyte subpopulation detection
The proportion of each subgroup of lymphocytes in the subjects' blood was detected by flow cytometry.
Measured: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
Cytokine levels
The levels of cytokines such as IL2, IL4 and IL6 in the peripheral blood serum of the subjects were detected by ELISA method.
Measured: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
C-reactive protein
C-reactive protein (CRP) is a key acute-phase reactant and a non-specific but highly sensitive biomarker of systemic inflammation. Primarily produced by the liver in response to pro-inflammatory cytokines, its level in the blood rises rapidly in the presence of acute inflammation, infection, or tissue injury.
Measured: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
CAR gene copy number
CAR gene copy number refers to the average number of CAR transgene copies integrated into the genome of a patient's engineered T cells. Monitoring this parameter is critical in CAR-T cell therapy for both safety and efficacy reasons. This indicator will be detected by qPCR.
Measured: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis(IPF)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329959
- Sponsor's protocol ID
- 2025-1161
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07329959
- Acronym / sponsor ID
- 2025-1161
- Conditions
- Idiopathic Pulmonary Fibrosis(IPF)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 9 Jan 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.
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fatal interstitial lung disease characterized by irreversible scarring, leading to respiratory failure. With limited treatment options and a poor prognosis, new therapies are urgently needed. This study investigates a novel cell therapy targeting pathological fibroblasts, a key driver of fibrosis.
Single-cell analyses identify CTHRC1+FAP+ fibroblasts as a collagen-producing subpopulation crucial in IPF progression. Chimeric antigen receptor (CAR) technology enables precise targeting of these cells. While CAR-Treg therapy has shown promise in preclinical models, its clinical translation requires careful safety evaluation regarding infection risk, potential tumor promotion, and immune reconstitution.
This trial employs an innovative approach using engineered dendritic cells (DCs). CAR technology is applied to generate immunosuppressive CAR-DCs (iCAR-DCs) designed to target FAP, localize to fibrotic lung areas, and attenuate fibrosis without eliciting a detrimental immune response. Preliminary mouse studies demonstrated that iCAR-DC administration following lung injury significantly reduced fibrosis without apparent organ toxicity and improved survival.
This single-arm trial aims to evaluate the efficacy and safety of this immunosuppressive CAR-DC therapy in patients with end-stage IPF. Key assessments will include changes in lung function, fibrosis extent on imaging, and comprehensive monitoring of potential adverse effects, particularly infections, tumor markers, and immune parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-DC Treatment | Experimental | Procedure: Leukapheresis, Biological: CAR-DCSubjects aged 18-75 with end-stage IPF meeting eligibility criteria will be enrolled. The study comprises: 1. Screening: Post-Informed Consent Form (ICF) signing, subjects are screened for eligibility. Only qualified subjects proceed. 2. Leukapheresis: Hospitalized subjects undergo ~100 ml blood collection via apheresis. Valid infectious disease testing is required. 3. Treatment: Hospitalized subjects receive a single infusion of autologous FAP-targeted iCDC cells. Pre-infusion criteria must be met (e.g., no significant infection, creatinine <2×ULN). 4. Post-Treatment Evaluation: Outpatient visits at Months 1, 3, and 6 post-infusion (Day 0). Assessments include pulmonary function tests, chest CT, 6-minute walk test, physical exams, vital signs, lab tests, and peripheral blood monitoring for iCDC cells. 5. Long-Term Follow-Up: For overall survival and long-term safety monitoring. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Aged between 18 and 75 years, inclusive, with a diagnosis of idiopathic pulmonary fibrosis (IPF).
- 2. Ability to verbally confirm understanding of the risks, benefits, and alternative treatments associated with immunosuppressive CAR-DC therapy. Provision of written informed consent by the patient or their legally authorized representative prior to participation.
- 3. Evidence of disease progression (worsening pulmonary fibrosis and declining lung function) despite treatment with standard therapies such as pirfenidone, nintedanib, or other appropriate regimens.
- 4. Meets at least one criterion indicating eligibility for lung transplantation due to interstitial lung disease, while not consenting to a transplant. The criteria include:
- A decline in forced vital capacity (FVC) ≥10% over a 6-month follow-up period.
Key exclusion criteria (13 listed)
- History of acute exacerbation of IPF within 4 weeks prior to screening or during the screening period.
- Presence of interstitial lung disease (ILD) other than IPF, including but not limited to: other forms of idiopathic interstitial pneumonia; ILD associated with fibrogenic agents, environmental exposures, or drug toxicity; other occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; or ILD related to systemic diseases (e.g., vasculitis, infections such as tuberculosis, connective tissue diseases). Cases with uncertain diagnosis require serological testing and/or multidisciplinary team review for confirmation.
- Presence of significant active infection.
- History of malignancy, except for malignancies treated with curative intent and with no recurrence for ≥5 years, resected basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix, or resected colonic polyps.
- Significant history of infectious diseases.
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 |
|---|---|---|
| LeukapheresisSubjects will be hospitalized in the Lung Transplant Ward to undergo leukapheresis, followed by an observation period. Eligible subjects, after signing the specific leukapheresis consent form, will undergo apheresis for the collection of approximately 100 ml of blood using a blood cell separator for the preparation of CAR-DC reagents. | Procedure or surgery | CAR-DC Treatment |
| CAR-DCSubjects will be hospitalized to receive autologous FAP-targeted immunosuppressive CAR-DC cell therapy, followed by an observation period. Based on our team's preclinical studies, the starting dose was determined to be 4×10⁵ cells/kg. This trial will employ a standard "3+3" dose-escalation design: Dose Level -1 at 1×10⁵ cells/kg, Dose Level 1 (starting dose) at 4×10⁵ cells/kg, and Dose Level 2 at 8×10⁵ cells/kg. The 3+3 dose escalation begins with the Dose Level 1 administered to a cohort of three subjects. If no dose-limiting toxicities (DLTs) are observed, the dose is escalated for the next cohort. If one DLT occurs, the cohort is expanded to six subjects at the same dose; escalation proceeds only if no further DLTs are seen in the expanded cohort. If two or more DLTs occur at any point within a cohort, dose escalation stops, and the maximum tolerated dose (MTD) is defined as the highest dose level with an observed DLT rate of less than 2 out of 6 subjects. | Biological | CAR-DC Treatment |
Primary outcome
The safety and efficacy of targeted FAP immunosuppressive CAR-DC in the treatment of end-stage idiopathic pulmonary fibrosis
Time frame: Within six months after CAR-DC therapy
The incidence of dose-limiting toxicity (DLT) and treatment-related adverse events (TEAE) within 14 days was evaluated in the targeted FAP immunosuppressive CAR-DC therapy for end-stage idiopathic pulmonary fibrosis.
14 secondary outcomes
The difference in forced vital capacity compared to the baseline before treatment
Time frame: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The difference in pulmonary carbon monoxide diffusion capacity compared to the baseline before treatment
Time frame: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The difference between the ratio of forced expiratory volume in the first second and forced vital capacity compared to the baseline before treatment
Time frame: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The difference between the 6-minute walk test result and the baseline value before treatment
Time frame: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The difference in the rate of change of pulmonary fibrosis area compared to the baseline before treatment as measured by quantitative CT
Time frame: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The total score of the St. George's Respiratory Questionnaire compared to the baseline before treatment
Time frame: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The total score of the MRC Questionnaire compared to the baseline before treatment.
Time frame: The three time points following CAR-DC cell therapy: Month 1, Month 3, and Month 6.
The times of the acute exacerbation of IPF
Time frame: Within six months after CAR-DC therapy
Number of participants with a set of laboratory tests
Time frame: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
Complete Blood Count
Time frame: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
Lymphocyte subpopulation detection
Time frame: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
Cytokine levels
Time frame: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
C-reactive protein
Time frame: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
CAR gene copy number
Time frame: The seven time points following CAR-DC cell therapy: Day 0, Day 3, Day 7, Day 14, Month 1, Month 3, and Month 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leukapheresis and CAR-DC in people with Idiopathic Pulmonary Fibrosis(IPF), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Man Huang, Ph.D (13906518699 ext. +86, huangman@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and efficacy of targeted FAP immunosuppressive CAR-DC in the treatment of end-stage idiopathic pulmonary fibrosis (time frame: Within six months after CAR-DC therapy). 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 9 Jan 2026.