Phase 1 Melanoma Trial, Recruiting NCT06942143 Sponsor: Guangzhou FineImmune Biotechnology Co., LTD. Condition: Melanoma
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Phase 1 Melanoma Trial, Recruiting

NCT06942143
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing and able to sign a consent form before any trial activities begin
  • You are between 18 and 75 years old (male or female)
  • Your cancer has not responded to your first round of treatment (first-line treatment has failed)
  • Your cancer has at least one measurable tumour, based on standard imaging guidelines
  • You test positive for a specific genetic marker called HLA-A*02, confirmed by the trial sponsor
  • Your tumour shows a protein called NY-ESO-1 in at least 20% of cells, confirmed by the trial sponsor
  • You are in good general health, able to carry out light activity and care for yourself (confirm with trial site)
  • Your doctors expect you to live for more than 3 months
  • You have not received any cancer treatments for at least 4 weeks before receiving the trial cell treatment
  • Your heart is pumping well, with a heart function score of 50% or above on an ultrasound
  • Your blood counts, kidney function, liver function, and clotting levels all meet the required levels set by the trial (confirm with trial site for exact values)
  • Women who could become pregnant must have a negative pregnancy test before starting treatment and agree to use effective contraception throughout the trial
  • You are able to attend regular check-up visits at the trial centre throughout the study

Who may not be able to join:

  • You have had major surgery, chemotherapy, radiotherapy, immunotherapy, or biological therapy within the 4 weeks before joining the trial
  • You are known to be allergic to any part of the trial treatment
  • You are still experiencing side effects from a previous surgery or treatment that have not improved to a mild level (confirm with trial site)
  • You have poorly controlled high blood pressure, a recent stroke (within 6 months), a recent heart attack (within 6 months), unstable chest pain, significant heart failure, a serious heart rhythm problem, or significant abnormalities on a heart tracing (ECG)
  • You have another serious illness affecting your organs or a serious mental health condition
  • You have an active infection requiring treatment, active tuberculosis, HIV, or active hepatitis A, B, or C (including those who carry the virus without symptoms)
  • You have an autoimmune disease such as lupus, vasculitis, or inflammatory bowel disease that the doctors feel makes the trial unsuitable for you (note: vitiligo does not exclude you)
  • You have taken certain immune-suppressing or immune-modifying medicines (such as steroids, cyclosporine, or interferon) within 4 weeks before the cell treatment
  • You have previously had an organ transplant, a stem cell transplant, or kidney dialysis
  • You have uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure
  • You have a known problem with alcohol or drug misuse
  • You are pregnant or currently breastfeeding
  • You have any other medical condition that the trial doctors feel would interfere with the trial
  • You do not have the legal ability to make decisions for yourself

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 86-02031605836

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Guangzhou FineImmune Biotechnology Co., LTD.
Registry
ClinicalTrials.gov
Start date
22 May 2025
Est. completion
25 April 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

DLT; MDT

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov