Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
The primary objective of this trial is to evaluate the safety and tolerability of the tumor neoantigen vaccine (SarcVac) in combination with a PD-1 antibody, with or without tumor-specific lymphocytes, in patients with advanced bone and soft tissue sarcoma who have failed first-line treatment. The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, in these patients and to evaluate whether the vaccine's efficacy demonstrates dose dependency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
Age≥18 years old, and≤70 years old ;
Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ;
Patients with first-line treatment failure ;
Disqualifiers
1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
White blood cell count ≥ 3.0 × 109 / L;
absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ;
absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L;
Trial design
Design model
Parallel
Treatments tested in this trial
Neoantigen vaccine + specific lymphocytes + anti-PD1 antibody
Biological/VaccineNeoantigen vaccine+ specific lymphocytes + anti-PD1 antibody
Neoantigen vaccine + anti-PD1 antibody
Biological/VaccineNeoantigen vaccine + anti-PD1 antibody
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Drug delivery mode 1Experimental treatment 1 intervention
Group B: Drug delivery mode 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events
The primary objective of this trial is to evaluate the safety and tolerability of the tumor neoantigen vaccine (SarcVac) in combination with a PD-1 antibody, with or without tumor-specific lymphocytes.
Time frame
120 daysSecondary outcomes
1
ORR
The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, and to evaluate whether the vaccine's efficacy demonstrates dose dependency.
Time frame
270 days2
DCR
The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, and to evaluate whether the vaccine's efficacy demonstrates dose dependency.
Time frame
270 daysSponsors and contacts
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Source ClinicalTrials.gov