Clinical trial · Interventional
Neo-MASCT Immunotherapy for Advanced NSCLC.
A Phase I/Ⅱ Open, Single Center, One-armed Trail, Neo - MASCT Treatment for Advanced NSCLC of the Safety and Efficacy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neoantigen (Neo)is a new targets for immune cells,that the DC neoantigen immunotherapy was more effective in triggering specific T-cell responses. Neo-MASCT using the DC vaccine and neoantigen T cells .Dendritic cells(DC) was induced from autologous peripheral blood,and be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL),similarly re-infused. The study is aimed to evaluate the safety of Neo-MASCT in patients with advanced NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neo-MASCT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neo-MASCT
- description
- Neoantigen Multiple Target Antigen Stimulating Cell Therapy ( Neo-MASCT)
- interventionNames
- Biological: Neo-MASCT
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
- timeFrame
- 1 to 2 years
- description
- The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Secondary outcomes (5)
- measure
- Clinical response of treatment according to RESIST v1.1 criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. The age is 18 to 80 years old. 2. The failure standard treatment subjects with advanced or relapsed NSCLC. 3. Informed consent of the patient/legal representative was signed. 4. Other anti-cancer treatments are at least one month apart from the study . 5. The eastern cancer cooperative group (ECOG) was rated 0-2. 6. According to the The reaction of solid tumors v1.1 (RECIST1.1 standard), there must be at least one measurable lesion . 7. The baseline blood and biochemical targets met the following criteria: The hemoglobin ≧ 85g/L ;White blood cells ≧ 3.0 x10 \^ 9 / L;Platelet ≧ 50 x10 \^ 9 / L;alanine aminotransferase (ALT), serum aspartate transaminase(AST) ≦ 2.5 times normal value limit; For patients with live metastases, ALT and AST are five times the normal limit; The alkaline phosphatase(ALP) ≦ 2.5 times the normal value; Serum bilirubin less than 1.5 times the normal value limit; Exclusion Criteria: 1. Participate in the planning or implementation of the research . 2. In addition to other clinical studies, unless it is an observational clinical study . 3. Being pregnant or planning a pregnancy. 4. Refuse to provide a blood specimen . 5. Allergic to sodium hydroquinone . 6. There is a history of organ transplantation 7. Brain transfer of the active period 8. Immunosuppressant drugs are currently in use or within 14 days prior to treatment. 9. The following exceptions are:Nasal, inhaled, topical use of steroid, or topical steroids (such as interjoint injection) . 10. Use a corticosteroid, no more than 10mg/day of prednisolone or its equivalent . 11. The use of steroids as a preventative treatment for hypersensitivity (such as CT scans) .
References
Publications (1)
- DERIVEDQiao Y, Hui K, Hu C, Wang M, Sun W, Liu L, Dong C, Jiang X. Efficacy and safety of PD-1 blockade-activated neoantigen specific cellular therapy for advanced relapsed non-small cell lung cancer. Cancer Immunol Immunother. 2025 Jan 3;74(2):60. doi: 10.1007/s00262-024-03906-z. PMID 39751937