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

NCT06302062 | Recruiting Phase 1 DMC

• 1 other identifier: FIT003-IIT
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumor; Tumor Associated Lymph Node T Cell; Immunotherapy

Keywords

TAL-T; cell therapy; Tumor Associated Lymph node T cell; Safety; Adverse Drug Event; Efficacy; Immunotherapy; Serplulimab Injection

Outcome Measures

Primary Outcomes (3)

• DLT

  The dosage of TAL-T was determined to limit toxicity

  At least 58 days

• MDT

  Determine the maximum tolerated dose of TAL-T

  At least 58 days

• 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

  At least 60 days

Secondary Outcomes (3)

• ORR

  one yaer

• PFS

  two years

• life quality score

  At least 70 days

Study Arms (2)

Cohort A

EXPERIMENTAL

Three patients were planned to be enrolled, and each subject received one to two cell transfusions.

Drug: Tumor Associated Lymph node T cell; Drug: cyclophosphamide; Drug: IL-2

Cohort B

EXPERIMENTAL

14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.

Drug: Tumor Associated Lymph node T cell; Drug: cyclophosphamide; Drug: IL-2; Drug: Serplulimab Injection

Interventions

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.

Also known as: TAL-T cells, TAL-T

Cohort A; Cohort B

cyclophosphamide DRUG

A one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion.

Cohort A; Cohort B

IL-2 DRUG

The IL-2 treatment will be continued for 5 days.

Also known as: Cellular interleukin 2, interleukin-2

Cohort A; Cohort B

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 .

Also known as: PD1 monoclonal antibody, PD1

Cohort B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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;
• \* having at least one resectable tumor-associated lymph node from which T cells can be successfully isolated;
• \* having an ECOG score of 0-1;
• \* having an expected survival of more than 6 months;
• \* 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;
• \* being willing to regularly come to the hospital for treatment, testing, evaluation, and management as required during the entire study period.

You may not qualify if:

• \* 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;
• Patients who have used large amounts of glucocorticoids or other immunosuppressants within 4 weeks;
• \* A history of severe hypersensitivity to any of the drugs used in this study;
• Known uncontrolled central nervous system (CNS) metastases and/or cancerous meningitis;
• \* Pregnant and lactating women, as well as women and men who were unable to cooperate with contraception during the study period;
• 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;
• \* 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;
• \* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
• \* 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;
• \* Known history of primary immunodeficiency virus infection or positive HIV test;
• \* Patients with chronic hepatitis B or HBV carriers of chronic hepatitis B virus (HBV), or patients with active hepatitis C should be excluded;
• \* Any of the following cardiovascular diseases

Sponsors & Collaborators

• Guangzhou FineImmune Biotechnology Co., LTD.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, 510700, China

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Cyclophosphamide; Interleukin-2; spartalizumab

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Central Study Contacts

Ying Cheng, Master

CONTACT

86-020-31605836; chengy02@fineimmu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: June 6, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CN (1)