Anti-cancer DC Cell Vaccination to Treat Solid Tumors

NCT06477614 | Recruiting Phase 1

• 1 other identifier: ZZVACCINE-DC-022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor, Adult; DC

Keywords

Solid Tumor; DC Vaccine; gp96

Outcome Measures

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.

  Six months

Secondary Outcomes (1)

• Percent of Patients with best response as either complete remission or partial remission.

  Six months

Study Arms (2)

Placental gp96 induced DC cell Vaccine

EXPERIMENTAL

Biological: DC cell Vaccine

Tumor-derived gp96 induced DC cell Vaccine

EXPERIMENTAL

Biological: DC cell Vaccine

Interventions

DC cell Vaccine BIOLOGICAL

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

Placental gp96 induced DC cell Vaccine; Tumor-derived gp96 induced DC cell Vaccine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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;
• Other severe diseases that the investigators consider not appropriate;
• Pregnant or lactating women;
• Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
• Other conditions that the investigators consider not appropriate.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, 51260, China

RECRUITING

Study Officials

• Zhenfeng Zhang, MD, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD, PhD

CONTACT

0086-020-39195965; zhangzhf@gzhmu.edu.cn

Bingjia He, MD

CONTACT

0086-020-39195965; 464677938@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: June 27, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2035
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

CN (1)