Health TrialsbyHealthPanel

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

ConditionsAdvanced Solid TumorTumor Associated Lymph Node T CellImmunotherapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou FineImmune Biotechnology Co., LTD.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

* being between the ages of 18 and 75;

having metastatic or locally advanced refractory/recurrent malignant solid tumors that have failed standard therapy or have failed to tolerate standard treatment;

having at least one measurable target lesion;

* voluntarily participating and signing an informed consent form;

Disqualifiers

* Experiencing moderate to severe infection or at risk of opportunistic infection;

* Present with active autoimmune disease (other than vitiligo or childhood asthma/allergies that have healed);

* Uncontrolled concomitant disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, arrhythmias (excluding stable atrial fibrillation), and significant carotid stenosis.

* Acute systemic infections, coagulation disorders or other serious cardiopulmonary diseases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 .

Treatment groups

23 Participants
are divided into 2 treatment groups
Group A: Cohort AExperimental treatment 3 interventions
Group B: Cohort BExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

DLT

The dosage of TAL-T was determined to limit toxicity

Time frame
At least 58 days
2

MDT

Determine the maximum tolerated dose of TAL-T

Time frame
At least 58 days
3

Number of participants with treatment-related adverse events as assessed by CTCAE V4.03

Keep record the adverse eventd experienced by subjects in 30 days after the last infusion

Time frame
At least 60 days

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
one yaer
2

PFS

The time between the subject receiving treatment and the onset of PD or death from any cause, whichever occurs first. If the subject had no events (PD or death), the last response assessment day was the cut-off time for PFS.

Time frame
two years
3

life quality score

ECOG 0-1

Time frame
At least 70 days

Other outcomes

Sponsors and contacts

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

Guangzhou FineImmune Biotechnology Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
Apply now