T Cell Therapy for Advanced Solid Tumors

An Open,Single-center,Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

This study is testing a new T cell therapy for people with advanced solid tumors that haven't responded to other treatments to see if it can help them feel better.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou FineImmune Biotechnology Co., LTD. (industry)
• Drugs / interventions: chemotherapy, Serplulimab
• Locations: 1 site (Guangzhou, Gaungdong)
• Trial ID: NCT06302062 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial evaluates the safety and efficacy of tumor-associated lymph node T cell therapy in patients with advanced solid tumors that have not responded to standard treatments. The trial includes two parts: one focusing on single-agent cell therapy and the other on a combination therapy with Serplulimab Injection. Participants will undergo a screening process, receive 1-2 infusions of cultured TAL-T cells, and be monitored for safety and treatment outcomes. The study aims to provide new therapeutic options for patients with metastatic or locally advanced refractory solid tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with metastatic or locally advanced refractory solid tumors that have failed standard treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a novel treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: While this approach is innovative, similar immunotherapy strategies have shown promise in other studies, indicating potential for success.

Eligibility criteria

Before conducting tumor-associated lymph node sampling, it is necessary to verify that subjects meet the inclusion criteria marked with an asterisk (\*). These criteria include:

1. \* being between the ages of 18 and 75;
2. having metastatic or locally advanced refractory/recurrent malignant solid tumors that have failed standard therapy or have failed to tolerate standard treatment;
3. having at least one measurable target lesion;
4. \* voluntarily participating and signing an informed consent form;
5. \* having at least one resectable tumor-associated lymph node from which T cells can be successfully isolated;
6. \* having an ECOG score of 0-1;
7. \* having an expected survival of more than 6 months;
8. \* female subjects with fertility potential must have a negative pregnancy test, and all men and women with fertility potential must consent to using medically effective contraception during the study period and for 12 months after the last dose of the study medication;
9. \* being willing to regularly come to the hospital for treatment, testing, evaluation, and management as required during the entire study period.

Before sampling tumor-associated lymph nodes, it is important to confirm that the subject does not meet any of the exclusion criteria marked with an asterisk (\*). These criteria include：

1. \* Experiencing moderate to severe infection or at risk of opportunistic infection;
2. \* Present with active autoimmune disease (other than vitiligo or childhood asthma/allergies that have healed);
3. \* Uncontrolled concomitant disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, arrhythmias (excluding stable atrial fibrillation), and significant carotid stenosis.
4. \* Acute systemic infections, coagulation disorders or other serious cardiopulmonary diseases;
5. Patients who have used large amounts of glucocorticoids or other immunosuppressants within 4 weeks;
6. \* A history of severe hypersensitivity to any of the drugs used in this study;
7. Known uncontrolled central nervous system (CNS) metastases and/or cancerous meningitis;
8. \* Pregnant and lactating women, as well as women and men who were unable to cooperate with contraception during the study period;
9. Previous anti-tumor therapy: within four weeks of radiotherapy, chemotherapy, one week after TKI inhibitor treatment, four weeks of investigational therapy or four half-lives, whichever is shorter;
10. \* Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study;
11. \* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
12. \* Known history of interstitial lung disease. Exclude subjects with high suspicion of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity; Or other moderate to severe lung diseases that seriously affect lung function;
13. \* Known history of primary immunodeficiency virus infection or positive HIV test;
14. \* Patients with chronic hepatitis B or HBV carriers of chronic hepatitis B virus (HBV), or patients with active hepatitis C should be excluded;
15. \* Any of the following cardiovascular diseases

    1. have evidence of acute or persistent episodes of myocardial ischemia;
    2. symptomatic pulmonary embolism is present;
    3. acute myocardial infarction occurred within 6 months prior to the initial study treatment;
    4. symptomatic congestive heart failure (grade 3 or 4 according to the New York Heart Association Functional Scale) occurred within 6 months prior to the first study treatment;
    5. Occurrence of grade 2 or more ventricular arrhythmias within 6 months prior to the first study treatment;
    6. cerebrovascular accident or transient ischemic stroke occurred within 6 months prior to the first study treatment
16. \* Subjects with pleural effusion, pericardial effusion, or ascites that, in the investigator\'s judgment, cannot be stably controlled by repeated drainage or other methods;
17. Have received a live vaccine within 30 days prior to the first dose or plan to receive a live vaccine during the study period;
18. \* Disease known to produce severe hypersensitivity to other monoclonal antibodies;
19. Any condition that the investigator believes may result in a risk of acceptance of the study drug treatment or interfere with the evaluation of the study drug or the safety of the subjects or the interpretation of the study results;
20. \* With a second primary tumor (within 5 years).

Where this trial is running

Guangzhou, Gaungdong

• Sun Yat-sen University Cancer Center — Guangzhou, Gaungdong, China (RECRUITING)

Study contacts

• Study coordinator: Ying Cheng, Master

Conditions: Advanced Solid Tumor, Tumor Associated Lymph Node T Cell, Immunotherapy, TAL-T, cell therapy, Tumor Associated Lymph node T cell, Safety, Adverse Drug Event