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H1299 Cell Lysates / Montanide (Registered Trademark) ISA-51 VG Adjuvant / Non Small Cell Lung Carcinoma · Phase 1/2 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a suspended Phase 1/2 trial registration evaluating a personalized cancer lysate vaccine (H1299) combined with Montanide ISA-51 VG and the IL-15 super-agonist N-803 as adjuvant therapy in PD-L1 negative NSCLC after surgery. No results have been posted; the record describes only the planned study design, primary outcome measures (immunologic response and safety), and recruitment status.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Carcinomas; age from 18 Years; to 120 Years. Intervention: 1/ Vaccine with Montanide Adjuvant; 2/ Vaccine with Montanide Adjuvant and N-803. n = 30. 1 site: United States.
This is a suspended Phase 1/2 trial registration evaluating a personalized cancer lysate vaccine (H1299) combined with Montanide ISA-51 VG and the IL-15 super-agonist N-803 as adjuvant therapy in PD-L1 negative NSCLC after surgery. No results have been posted; the record describes only the planned study design, primary outcome measures (immunologic response and safety), and recruitment status.
No efficacy data (recurrence-free survival, overall survival) are reported; primary endpoints are surrogate markers (immunologic response) and safety.
The source did not state who this applies to in practice.
This is a Phase 1/2 trial registration with recruitment suspended; no results are posted, making it an early-stage study design record without outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05642195). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: SUSPENDED. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Carcinomas. Interventions: BIOLOGICAL: Montanide (Registered Trademark) ISA-51 VG Adjuvant; BIOLOGICAL: H1299 Cell Lysates; DRUG: N-803; DEVICE: Ventana PD-L1 (SP263 or SP142) assay. Primary outcome measures: Phase II Component: To assess the frequency of immunologic responses to purified CT-X and autosomal CT antigens in NSCLC participants following vaccinations with H1299 cancer cell lysate and Montanide ISA-51 VG adjuvant in combination with N-803 , 1 month following first 6 vaccinations, and every 6 months during retreatment; Phase I Component: To determine the safety of H1299 lung cancer cell lysate vaccines administered with Montanide (Registered Trademark) ISA-51 VG adjuvant and N-803 , before each cycle, every 2 weeks between vaccines 1 & 2 (AE only), at each treatment evaluation, and at the safety visit. Brief summary: Background: Surgery is the primary treatment for non-small cell lung cancer (NSCLC) that is diagnosed in its earlier stages. But the tumors often return. Radiation and chemotherapy can improve survival in some people who have had surgery for NSCLC, but these treatments also cause serious side effects. A new approach, called immunotherapy, may be a better way to stop NSCLC tumors from coming back. Objective: To test a new treatment (H1299 lung cancer cell vaccine combined with the drug N-803) in people who received surgery for NSCLC. Eligibility: Adults aged 18 years or older with no sign of disease after surgery for NSCLC. Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans. Study treatment will be given in 28-day cycles. Participants will visit the clinic on the first day of each cycle. They will receive 2 treatments at each visit: The study vaccine is given as 2-4 small shots under the skin of the thigh or arm. N-803 is given as a shot under the skin of the abdomen. Treatment will continue for 6 cycles. Blood tests and imaging scans will be repeated throughout the study. Participants will have a blood test 1 month after receiving the 6th vaccine. Some participants may then resume taking N-803; they may also receive 2 more vaccinations at 3 and 6 months after their previous treatment. Follow-up visits will continue for up to 5 years.
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