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

ConditionsTumor Associated Lymph Node T CellAdvanced Solid TumorImmunotherapySerplulimab Injection
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Tumor Associated Lymph node T cell

    Biological/Vaccine

    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.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Exploration of the dosage range and Expansion phaseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

AEs and SAEs

Incidence, severity and drug correlation of 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

Secondary outcomes

1

ORR

The proportion of subjects receiving a confirmed optimal response of PR or above which was evaluation according to RECIST or iRECIST principles.

Time frame
Two years
2

DCR

The proportion of subjects whose response was assessed as CR, PR, or stable disease (SD) to the total number of subjects for which response could be assessed

Time frame
Two years
3

DOR

The first assessment of efficacy was CR or PR up to PD or the time of death from any cause

Time frame
Two years
4

PFS

The time from the beginning of preconditioning until disease progression (PD) or death from any cause

Time frame
Two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou FineImmune Biotechnology Co., LTD.

Lead sponsor

Sun Yat-sen University

Collaborator

Source ClinicalTrials.gov
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