Neoantigen Derived DCs as Cancer Treatment

Sponsor
National Health Research Institutes, Taiwan
Study ID
NCT05767684
Phase
PHASE1
Status
Unknown

Conditions

  • Refractory Tumor
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dendritic Cell Vaccine — BIOLOGICAL
    Approximately 1.5 x 10\^6±20% cells will be subcutaneously injected to the patient's inguinal area (either left side or right side can be injected, only one area will be injected each time) on day 1, 8, 15, 29, 85, 141, 197, 253 and 309.
  • Lenvatinib — DRUG
    Lenvatinib 10mg/day on day 43-77
  • Nivolumab — DRUG
    Nivolumab 3mg/kg on day 43, 57 and 71.

Study Details

Tumor lysate or carcinoembryonic antigen (CEA) derived DCs-based therapy is safe and can elicites remarkable T-cell responses but mostly did not really transfer into significant clinical benefit. One possible reason is the lack of effective antigen and the immunosuppressive microenvironment. Now we are exploring another new strategy, prediction of neoantigen for priming DCs as cell-based therapy with or without booster of anti-VEGF/anti-PD-1.

Key Dates

Start date
Jun 1, 2023
Status verified
Feb 2023
Primary completion
Mar 30, 2025
Completion
Mar 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: DCs monotherapy
    DCs injection on day 1, 8, 15, 29, 85, 141, 197, 253 and 309.
  • Experimental: Arm 2: DCs with booster of anti-VEGF/anti-PD-1.
    DCs injection on day 1, 8, 15, 29, 85, 141, 197, 253 and 309 plus lenvatinib 10mg QD on day 43-77 and nivolumab 3mg/kg on day 43, 57 and 71.

Primary Outcome Measure

Number of subjects experienced limiting toxicities in the first 6 weeks. [ Time Frame: 6 weeks ]

Central Contacts

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