Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

Sponsor
Guangzhou FineImmune Biotechnology Co., LTD.
Study ID
NCT06302062
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Immunotherapy
  • 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 — DRUG
    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 (FIT003 TAL-T). After lymphodepletion, patients are infused with FIT003 TAL-T.
  • cyclophosphamide — DRUG
    A one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion.
  • IL-2 — DRUG
    The IL-2 treatment will be continued for 5 days.
  • Serplulimab Injection — DRUG
    In group B, Serplulimab Injection was injected before and after cell transfusion. If two cell transfusions were performed,Serplulimab Injection were given again .

Study Details

A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection. To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others.

Key Dates

Start date
Jun 6, 2023
Status verified
Nov 2024
Primary completion
Dec 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
23 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Three patients were planned to be enrolled, and each subject received one to two cell transfusions.
  • Experimental: Cohort B
    14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.

Primary Outcome Measure

DLT [ Time Frame: At least 58 days ]

Central Contacts

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