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New treatment option for Solid Tumors, Adult
Official title TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors
ClinicalTrials.gov ID: NCT06088472
What this study is testing
What is TIL injection?
TIL injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for solid tumors, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 1\. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;
- 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
- 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other...
You likely can't join if
- 1\. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone...
- 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring...
- 3\. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary...
- 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃...
- 5\. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
- 6\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
See the full eligibility criteria
- 1\. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;
- 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
- 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies, and at least tissue blocks with a volume of≥0.5 cubic...
- 1\. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
- 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent...
- 3\. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
- 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
- 5\. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
- 6\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
- 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum...
The study team makes the final eligibility decision.
Where it's taking place
- Xuzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xuzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.