Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
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
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
Treatments tested in this trial
- Tumor Associated Lymph node T cell
- cyclophosphamide
- IL-2
- Serplulimab Injection
Treatment groups
23 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov