A Phase I/ II Study of Fragmented Autoantigen Stimulated T-cell-immunotherapy Combined with Radiotherapy (FAST-CR)

NCT06756295 | Not Yet Recruiting Early Phase 1

• 1 other identifier: GCOG0052
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation and exploration of the phase I/II clinical safety and efficacy of personalized FAST(Radiation fueled antigens stimulated T-cell immunotherapy )cancer vaccine combined with radiotherapy.

Conditions

Breast Cancer, Colorectal Cancer; Melanoma; Lung Cancer

Keywords

tumor vaccine; immunogenic cell death; TCV

Outcome Measures

Primary Outcomes (1)

• safe

  The primary endpoint of this study: The Phase I safety evaluation will involve a 3×3 dose escalation of the vaccine (based on a similar international clinical trial, NCT05366062, with low, medium, and high-dose groups, each group receiving 500,000, 1 million, and 2 million cancer cell fragments, respectively, with 3 participants per group). The safety profile will be summarized, including the incidence and severity of adverse events (Evaluation criteria: Treatment toxicity graded according to CTCAE 5, (Common Terminology Criteria for Adverse Events version 5). If the summary of Phase I toxicity shows no significant higher toxicity compared to existing immunotherapies, the study will proceed to the Phase II efficacy trial.

  one month

Secondary Outcomes (2)

• OS (Overall Survival)

  5 years

• DFS (disease free survival)

  5 years

Study Arms (2)

standard treatment + adjuvant

NO INTERVENTION

Patients in the control group include two categories: (1) surgical patients who receive standard postoperative treatment according to guidelines, and (2) non-surgical patients who receive standard RT.

Standard treatment + individualized tumor FAST vaccine combination (including adjuvant)

EXPERIMENTAL

Surgical Patients: These patients will receive standard postoperative treatment according to guidelines. In Phase I of the trial, they will be randomly administered the aforementioned low, medium, or high doses of the FAST vaccine (P12). In Phase II, the optimal dose will be selected for each patient (as assessed by an expert panel). Non-Surgical Patients: Before starting the tumor vaccine, these patients will first undergo three sessions of precision radiotherapy (the doctor will determine whether the patient should receive 2 Gy × 3 or 8 Gy × 3, depending on the patient's condition). After completing the radiotherapy, the individualized tumor vaccine will be administered one week later. Similarly, in Phase I, these patients will receive the low, medium, or high doses of the FAST vaccine (P12) in a randomized manner. In Phase II, the optimal dose will be selected for each patient (as assessed by the expert panel). Tumor vaccine treatment will be administered in cycles of 5

Biological: individualized tumor FAST vaccine combination (including adjuvant)

Interventions

individualized tumor FAST vaccine combination (including adjuvant) BIOLOGICAL

Using the patient's individual tumor tissue, an autologous FAST (Fragmented Autoantigen Stimulated T-cell Immunotherapy) vaccine is prepared.

Standard treatment + individualized tumor FAST vaccine combination (including adjuvant)

Eligibility Criteria

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

You may qualify if:

• \- Voluntarily agree to participate in this study. Age: 18-80 years, regardless of gender. Pathological and imaging diagnosis of advanced or recurrent malignant tumors. The patient must have previously received systemic standard treatment that has failed or led to disease progression, with no effective first-line treatment options available for advanced tumors (effective treatment options refer to the latest clinical guidelines published by the "Chinese Society of Clinical Oncology"). Alternatively, the patient may have undergone standard surgical treatment for tumor relapse prevention.
• At least one measurable lesion on imaging (excluding patients who have undergone surgical treatment).
• Expected survival ≥ 6 months. ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1. No infectious diseases: HIV antibody negative. Normal hematological function: White blood cells ≥ 3000 cells/µL, hemoglobin ≥ 9 g/dL, platelets ≥ 75,000 cells/µL, absolute neutrophil count \> 1000 cells/mm³.
• Normal renal function: Serum creatinine (Cr) ≤ ULN × 1.5. Normal liver function: Serum ALT/AST levels less than three times the upper limit of normal.
• The patient must be willing to sign an informed consent form and able to comply with the treatment plan.
• The patient must undergo tumor resection or biopsy (for vaccine preparation) and peripheral blood collection (for efficacy and prognosis evaluation).

You may not qualify if:

• \- Patients who do not have enough tumor resected or puncture tissue for vaccine production.
• Patients who have failed third-line therapy, and whose tumor location or type is not suitable for radiotherapy (as evaluated by the expert group).
• Patients whose tumor tissue preparation for the vaccine does not meet the efficacy assessment criteria before enrollment (individualized FAST vaccine Elispot test, see Appendix 4 for specific testing protocol).
• Patients with a history of bone marrow or stem cell transplantation. Patients currently participating in other therapeutic clinical trials; Traditional Chinese medicine clinical trials.
• Patients with active bacterial or fungal infections as per NCI-CTC (National Cancer Institute Common Terminology Criteria for Adverse Events) CTCAE 5.0.
• Patients infected with HIV (Human Immunodeficiency Virus), HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), severe asthma, autoimmune diseases, immunodeficiency, or those undergoing immunosuppressive therapy.
• Patients with herpesvirus infection (except those whose lesions have scabbed for more than 4 weeks).
• Patients with respiratory viral infections (except those who have been cured for more than 4 weeks).
• Patients with severe coronary artery or cerebrovascular diseases, or other diseases that the investigator considers should be excluded.
• Patients with clinical, psychological, or social factors that affect their ability to provide informed consent for the study.
• Patients with a history of autoimmune diseases, such as but not limited to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients with autoimmune-related thyroid diseases and vitiligo are allowed.
• Patients with severe chronic or acute comorbidities, such as heart disease (NYHA Class III or IV), liver disease, or other diseases that the principal investigator considers to pose unnecessary high risk in relation to the study drug treatment.
• Patients who have a second malignant tumor at the same time (or within the past 5 years), except for melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other treated carcinoma in situ.
• Patients with active acute or chronic infections, including urinary tract infections, HIV (as confirmed by ELISA and Western Blot). HIV-infected individuals may be excluded because immunosuppression could prevent them from responding to the vaccine; chronic hepatitis patients may be excluded due to concerns that vaccination could exacerbate their hepatitis.
• Patients with a history of drug or peptide allergies, or allergies to other potential immunotherapies.

Sponsors & Collaborators

• Fengming Kong: lead
• The University of Hong Kong-Shenzhen Hospital: collaborator
• Peking University: collaborator

Related Publications (1)

• Li Y, Chen H, Shen Q, Liu Y, Li P, Ma Y, Wang Y, Li S, Yan X, Liu L, Shuai J, Wu M, Ouyang Q, Kong FS, Yang G. Fragment Autoantigens Stimulated T-Cell-Immunotherapy (FAST) as a Fast Autologous Cancer Vaccine. Adv Sci (Weinh). 2025 Jul;12(26):e2502937. doi: 10.1002/advs.202502937. Epub 2025 Mar 26.

  PMID: 40135850 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Melanoma; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Feng-Ming (Spring) Kong

CONTACT

+86 18807550703; kong0001@hku.hk

Gen Yang

CONTACT

+86 15010272716

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tenured Clinical Professor

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 1, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share