Clinical trialPhase 1Unknown
Neoantigen-expanded Autologous Immune Cell Therapy
A Phase I Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Neoantigen-expanded Autologous Immune Cell Therapy for Solid Tumors
- Outcome
- Outcome unknown
- Cell product
- Other cell therapies
Neoantigen-expanded Autologous Immune Cell Therapy
- Target antigen
- neoantigen (personalised)
Neoantigen-expanded Autologous Immune Cell Therapy
- Cell source
- Autologous
Neoantigen-expanded Autologous Immune Cell Therapy
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 9 April 2021
- Listed end
- 30 June 2023
- Enrollment
- 9 participants
- Sites
- 1
- Primary outcomes
- Acute, subacute toxicities and AEs of neoantigen-expanded autologous immune cell therapy.; Dose-limiting toxicity (DLT); Maximum tolerated dose (MTD)
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 25 August 2021
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Brief summary public domain (ClinicalTrials.gov)
The investigators aim to investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients.
Detailed description public domain (ClinicalTrials.gov)
Cancer is the leading cause of death in the world. However, the response of traditional treatments(such as chemotherapy, radiotherapy, or target therapy) is yet limited. In this clinical trial study, the investigators will investigate the patient's tumor neoantigen to generate "personalized cancer vaccine" and then to expand autologous dendritic cells-cytokine-induced killer cells (DC-CIK). The autologous DC-CIK will be cultured in vitro and re-infused into patients. The similar clinical trial design and immune cell preparation have been recently published in international journals. Though adverse reactions (AE) have been reported, and there was no cases with severe adverse events (SAE), suggesting the safety of autologous immune cell therapy against cancers. The main propose of this clinical trial is to improve the treatment for solid tumors. By conducting this clinical trial, the investigators aim to enroll patients with refractory advanced solid tumors, and develop "neoantigen-expanded autologous immune cell therapy". The investigators will utilize "neoantigens" to expand the patients' autologous peripheral blood mononuclear cells into DC-CIK. The enrolled patients will receive autologous DC-CIK of 10 doses within 4\~5 months of treatment, and the safety, tolerability, and efficacy of this immune cell therapy will be evaluated.
Intervention public domain (ClinicalTrials.gov)
Drug: Neoantigen-expanded cell therapy. (Neoantigen-expanded autologous DC-CIK cells.). Infusion of personalized neoantigen-expanded T (CIK) cells
Arm public domain (ClinicalTrials.gov)
Low dose of neoantigen-based cell therapy (N=3+3) (experimental): (1±20%) × 109cells/200 mL every 14 days for 10 doses
Arm public domain (ClinicalTrials.gov)
Medium dose of neoantigen-based cell therapy (N=3+3) (experimental): (3±20%) × 109cells/200 mL every 14 days for 10 doses
Arm public domain (ClinicalTrials.gov)
High dose of neoantigen-based cell therapy (N=3+3) (experimental): (9±20%) ×109cells/400 mL every 14 days for 10 doses