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Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05235607
Enrollment
60
Registered
2022-02-11
Start date
2022-03-01
Completion date
2023-12-02
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Carcinoma, Colorectal Cancer, Melanoma

Keywords

Melanoma, Bladder Cancer, Colorectal Cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy

Brief summary

This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.

Interventions

BIOLOGICALTumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration

subcutaneous administration

Sponsors

Sichuan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age:18-75 years * Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions; * Failed in the previous standard therapy; * ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points; * The estimated survival period is ≥3 months; * Rehabilitate from previous therapy; * Adequate organ functions; * Patient's written informed consent;

Exclusion criteria

* Tumor emergencies; * Abnormal coagulation function; * Contagious diseases, such as HIV, HBV, HCV infection; * Mental disorders; * Concomitant tumors; * Immunological co-morbidities

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.03 months after the last administration of cellsNumber of participants with treatment-related adverse events as events as assessed by CTCAE v4.0

Secondary

MeasureTime frame
Number of participants with Overall survival as assessed by RECIST1.1through study completion, an average of 1 year

Countries

China

Contacts

Primary ContactJi-Yan Liu, Prof
liujiyan1972@163.com028-85422039

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026