Clinical Trials in China / NCT06488950
Recruiting
Early Phase 1
A Study of TIL in Advanced Solid Tumors (DFGD)
NCT06488950 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Solid TumorTumor Infiltrating LymphocytesTreatment Side EffectsEffects of Immunotherapy
Investigational drug(s) / intervention(s)
GC203 TIL(gene-edited TIL) or autologous TILs: the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample
Study summary
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Eligibility
Inclusion Criteria:
* have one the tumor resection for TILs production and successfully produced；
* Age: 18 years to 75years;
* Histologically diagnosed as solid tumors;
* Expected life-span more than 3 months;
* ECOG score 0-1;
* Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;
* At least 1 evaluable tumor lesion;
Exclusion Criteria:
* with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
* Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
* Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \< 95%;
* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
* Significant cardiovascular anomalies
Primary outcome measure(s)
- Adverse Events — 6 months
To characterize the safety profile of TILs in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Third Affiliated Hospital of Naval Medical University | Shanghai | China | Recruiting |
More Shanghai Juncell Therapeutics trials in China
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Other trials for the same condition
A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
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A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors
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A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06488950 on ClinicalTrials.gov ↗ ← All trials in China