Anti-cancer DC Cell Vaccination to Treat Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
Placental or tumor-derived heat shock protein gp96 is collected, purified, and stored. The DC cells are isolated from the patient's blood and then cocultured with the gp96 to obtain the activated DC cell product. The manufactured DC cells are subcutaneously or intra-tumor injected into the patient. Clinical studies will be performed to test anti-cancer function of the DC vaccination for immunotherapy of cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the DC vaccine immunotherapy on advanced cancers will firstly be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Had accepted gene therapy before;
Severe virus infection such as HBV, HCV, HIV, et al;
Known HIV positivity;
Active infectious disease related to bacteria, virus,fungi,et al;
Trial design
Design model
Parallel
Treatments tested in this trial
DC cell Vaccine
Biological/VaccineDeliver DC cell vaccine into patients for anti-ancer therapy.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Placental gp96 induced DC cell VaccineExperimental treatment 1 intervention
Group B: Tumor-derived gp96 induced DC cell VaccineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Patients with Dose Limiting Toxicity
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
Time frame
Six monthsSecondary outcomes
1
Percent of Patients with best response as either complete remission or partial remission.
Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.
Time frame
Six monthsSponsors and contacts
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Source ClinicalTrials.gov