Anti-cancer DC Cell Vaccination to Treat Solid Tumors

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor, Adult; DC

Treatments: Biological: DC cell Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06477614

ZZVACCINE-DC-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Placental gp96 induced DC cell Vaccine

Experimental group

Treatment:

Biological: DC cell Vaccine

Tumor-derived gp96 induced DC cell Vaccine

Experimental group

Treatment:

Biological: DC cell Vaccine