A Phase 1 interventional study of Leukapheresis and CAR-DC in Idiopathic Pulmonary Fibrosis(IPF), sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1, Interventional, and Treatment
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.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's planned enrollment of 8 is below the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
Exclusion Criteria:
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.
Procedure: Leukapheresis · Biological: CAR-DC
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.
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.
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.
Time frame: Within six months after CAR-DC therapy
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
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.
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
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.
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
The proportion of each subgroup of lymphocytes in the subjects' blood was detected by flow cytometry.
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
The levels of cytokines such as IL2, IL4 and IL6 in the peripheral blood serum of the subjects were detected by ELISA method.
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
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.
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
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.
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.
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Plan to share: No
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Idiopathic Pulmonary Fibrosis→
Second Affiliated Hospital, School of Medicine, Zhejiang University