BridgeMD
New treatment option for Melanoma
Official title A Study of GC101 TIL in Advanced Melanoma
ClinicalTrials.gov ID: NCT06703398
What this study is testing
What is GC101 TIL?
GC101 TIL is an investigational medicine, being studied as a potential treatment for melanoma.
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
- 98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial，this trail is expected to be finished in 24 months
- Phase 2: a mid-size study of how well it works
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 75
You may be able to join if
- Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
- Aged ≥18 years and ≤75 years, regardless of gender;
- Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) ;
- Patients who have failed or resisted to PD-1 antibodies；
- Patients must have failed or resisted to at least two frontlines systemic tehrapy(if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK...
You likely can't join if
- Patients receive any drug under study within 28 days prior to screening;
- Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at...
- Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;
- Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia...
- Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;
- Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and/or diastolic...
See the full eligibility criteria
Who can join
- Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
- Aged ≥18 years and ≤75 years, regardless of gender;
- Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) ;
- Patients who have failed or resisted to PD-1 antibodies；
- Patients must have failed or resisted to at least two frontlines systemic tehrapy(if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK inhibitor; if knowed with NRAS mutate, then need to failed to...
- TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.)...
- ECOG performance status 0-1;
- Expected survival time \>3 months;
- With sufficient hematology and end-organ function;
- Good compliance and able to adhere to the study visit plan and other agreement requirements.
What rules you out
- Patients receive any drug under study within 28 days prior to screening;
- Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer...
- Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;
- Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, hypothyroidism etc., which in the judgment of the investigator pose no...
- Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;
- Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg) even with standardized treatment or any...
- Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation...
- Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and/or...
- Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;
- With other serious organic diseases or mental disorders;
- Suffering from systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including but not limited to active tuberculosis;
- Suffering from infectious diseases such as hepatitis B, hepatitis C, syphilis, AIDS, etc;
- Individuals with active autoimmune diseases (such as eczema, vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment within the past two years, other autoimmune diseases that are not...
- Any NCI CTCAE 5.0 immune-related adverse reaction (iRAE) grade ≥3 occurred during any previous immunotherapy(except for cases where it recovered to ≤1 after treatment or reached stability as assessed by the...
- Those who had undergone organ allotransplantation, allogeneic stem cell transplantation and renal replacement therapy;
- Pulmonary fibrosis, interstitial lung disease (including past history and current condition), acute lung disease;
- Those with leptomeningeal metastasis;
- Patients with clinical symptoms of central nervous system metastases (such as cerebral edema, requiring hormone intervention, or progression of brain metastases), Patients who have previously received treatment for...
- Women who are pregnant or breastfeeding;
- There is a history of TIL cell therapy, allogeneic T cell therapy, or NK cell therapy within 6 months;
- Situations that are not suitable for enrollment assesed by investigators;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.