A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors

Sponsor
Guangzhou FineImmune Biotechnology Co., LTD.
Study ID
NCT06716619
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Immunotherapy
  • Serplulimab Injection
  • Tumor Associated Lymph Node T Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tumor Associated Lymph node T cell — BIOLOGICAL
    At least one lymph sample is resected from each participant, then it is separated and cultured ex vivo to expand the population of Tumor Associated Lymph node T cells . After lymphodepletion, patients are infused with TAL-T.
  • Serplulimab Injection — DRUG
    Srulizumab injection was given intravenous infusion both before and after the TAL-T cells infusion.

Study Details

A Phase I clinical trial of the safety and tolerability of tumor-associated lymph node T cell injection in patients with advanced malignant solid tumors, including but not limited to melanoma, head and neck tumors, cervical cancer, and non-small cell lung cancer.

Key Dates

Start date
Feb 13, 2025
Status verified
Mar 2025
Primary completion
Dec 19, 2026
Completion
Dec 19, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Exploration of the dosage range and Expansion phase
    In the exploration dosage range phase, the safety data accumulated from the trial will be used to evaluate whether the safety of TAL-T cell therapy meets the requirements and decide whether to terminate the study. Exploration of the dosage range is divided into three dose phases, and the upper limit of the maximum dose is constantly expanded. After completion of exploration study, three types of preferred tumor will be choosed by sponsor. During the expansion phase, the actual number of participants in each cohort may be adjusted based on the obtained trial results to further evaluate the safety, tolerability, and efficacy of TAL-T cell infusion.

Primary Outcome Measure

AEs and SAEs [ Time Frame: All aes and saes are to be collected from the time the pre-screened informed consent is signed until 54 weeks after cell retransfusion, unless the subject withdraws from the study early for any reason ]

Central Contacts

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