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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou FineImmune Biotechnology Co., LTD.

About this trial

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.

Eligibility criteria

Qualifiers

Sign a written informed consent (ICF) and be able to comply with the visit and related procedures required by the program;

Age ≥18 years old, and ≤75 years old, male and female;

ECOG score 0-1;

Expected survival is not less than 12 weeks;

Disqualifiers

meningeal metastases, and/or active brain metastases;

Have previously received allogeneic bone marrow transplantation, organ transplantation or are waiting for transplantation;

HBsAg positive hepatitis B; HCV-Ab positive hepatitis C; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis antibody positive; Cytomegalovirus (CMV) IgM antibody positive; Human herpesvirus type 4 (EBV) IgM positive; Human T-lymphocytophilic virus (HTLV-Ⅰ/Ⅱ) antibody positive;

Received any fluorouracil chemotherapeutic drugs or small molecule targeted drugs within 14 days or 5 half-lives (whichever is shorter) prior to pretreatment; Received any antitumor biologic or non-fluorouracil chemotherapeutic drugs within 28 days or 5 half-lives (whichever is shorter) prior to pretreatment; Received radical radiotherapy or extensive radiotherapy within 28 days prior to pretreatment (except local non-target palliative radiotherapy for symptom relief within 14 days prior to pretreatment); Received Chinese medicine/Chinese herbal medicine with anti-tumor indications and local interventional therapy within 14 days prior to pretreatment;

Trial design

Treatments tested in this trial

  • Tumor Associated Lymph node T cell
  • Serplulimab Injection

Treatment groups

32 Participants
are divided into 1 treatment group

Sponsors and collaborators