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Trial Title:
Anti-cancer DC Cell Vaccination to Treat Solid Tumors
NCT ID:
NCT06477614
Condition:
Solid Tumor, Adult
DC
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumor
DC Vaccine
gp96
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
DC cell Vaccine
Description:
Deliver DC cell vaccine into patients for anti-ancer therapy.
Arm group label:
Placental gp96 induced DC cell Vaccine
Arm group label:
Tumor-derived gp96 induced DC cell Vaccine
Summary:
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.
Detailed description:
1. Choose appropriate patients with advanced solid cancers, with written consent for
this study;
2. Perform biopsy to get fresh sample for generation gp96 protein; Collect DC cells
from the cancer patient;
3. Produce appropriate DC cell vaccine and deliver the vaccine into selected patients
via local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with vaccine aduvants or
PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with advanced cancer; 2. Life expectancy >12 weeks; 3. Adequate heart,
lung, liver, kidney, and blood function; 4. Available high quality vaccine for human
use; 5. Informed consent explained to, understood by and signed by patient/guardian.
Patient/guardian given copy of informed consent.
- Exclusion Criteria:
1. Had accepted gene therapy before;
2. Severe virus infection such as HBV, HCV, HIV, et al;
3. Known HIV positivity;
4. Active infectious disease related to bacteria, virus,fungi,et al;
5. Other severe diseases that the investigators consider not appropriate;
6. Pregnant or lactating women;
7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone
equivalent/kg/day);
8. Other conditions that the investigators consider not appropriate.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guanzhou
Zip:
51260
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenfeng Zhang, MD,PhD
Phone:
02034153532
Email:
zhangzhf@gzhmu.edu.cn
Start date:
June 5, 2024
Completion date:
December 30, 2035
Lead sponsor:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
Second Affiliated Hospital of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06477614
