Anti-cancer DC Cell Vaccination to Treat Solid Tumors

NCT ID: NCT06477614

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-05
• Study Completion Date: 2035-12-30

Brief 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.

Conditions

Solid Tumor, Adult; DC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placental gp96 induced DC cell Vaccine

Group Type: EXPERIMENTAL

DC cell Vaccine

Intervention Type: BIOLOGICAL

Deliver DC cell vaccine into patients for anti-ancer therapy.

Tumor-derived gp96 induced DC cell Vaccine

Group Type: EXPERIMENTAL

DC cell Vaccine

Intervention Type: BIOLOGICAL

Deliver DC cell vaccine into patients for anti-ancer therapy.

Interventions

DC cell Vaccine

Deliver DC cell vaccine into patients for anti-ancer therapy.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenfeng Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenfeng Zhang, MD, PhD

Role: CONTACT

zhangzhf@gzhmu.edu.cn

0086-020-39195965

Bingjia He, MD

Role: CONTACT

464677938@qq.com

0086-020-39195965

Facility Contacts

Zhenfeng Zhang, MD,PhD

Role: primary

zhangzhf@gzhmu.edu.cn

02034153532

Other Identifiers

ZZVACCINE-DC-022

Identifier Type: -

Identifier Source: org_study_id