Phase 1 Kidney Cancer Trial, Recruiting NCT06198296 Sponsor: Baylor College of Medicine Condition: Kidney Cancer
Back to Kidney Cancer

Phase 1 Kidney Cancer Trial, Recruiting

NCT06198296
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:

To donate cells (Procurement phase):

  • People aged 21 years or older
  • People who have a solid tumour that tests positive for a protein called GPC3, confirmed by a specific laboratory test showing a sufficient amount of the protein in tumour cells
  • People whose general health and ability to perform daily activities meets a minimum score on a standard health scale (Lansky or Karnofsky score of 60% or above)
  • People with a life expectancy of at least 16 weeks
  • People with liver cancer (hepatocellular carcinoma) whose disease falls within a certain stage range (Barcelona Clinic Liver Cancer Stage A, B, or C) and whose liver function score is below a certain threshold (confirm with trial site)
  • People, or their legal guardian, who have been fully informed about the trial and have signed a consent form

To receive treatment (Treatment phase):

  • People aged 21 years or older with a GPC3-positive solid tumour
  • People whose general health meets the same minimum activity score as above
  • People with a life expectancy of at least 12 weeks
  • People with liver cancer whose disease is Stage A, B, or C and whose liver function score meets the required threshold (confirm with trial site)
  • People whose kidneys, liver, blood counts, and oxygen levels meet specific minimum values as determined by blood and other tests (confirm with trial site for exact values)
  • People whose cancer has returned or stopped responding to standard treatment, and who have already completed at least one further round of treatment after that
  • People who have recovered from the side effects of any previous cancer treatments
  • People who are sexually active and willing to use effective contraception for 3 months after receiving the cell infusion
  • People, or their legal guardian, who have been fully informed about the trial and have signed a consent form

Who may not be able to join:

For both the cell donation and treatment phases:

  • People who have previously had an allergic reaction to products containing mouse proteins, or who have developed antibodies against mouse proteins as a result of prior treatment with mouse-derived therapies
  • People who have previously had an organ transplant
  • People who are known to be HIV positive
  • People who currently have an active bacterial, fungal, or viral infection (note: Hepatitis B and Hepatitis C infections are exceptions to this rule — confirm with trial site)

For the treatment phase only:

  • People who are pregnant or breastfeeding
  • People with an infection that is not under control
  • People currently taking systemic steroid medications at or above a certain dose, unless the dose has been reduced or stopped at least 24 hours before the planned cell infusion

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 28 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

Principal Investigator: Premal Lulla, MD, Baylor College of Medicine

Phone: (713) 441-1450

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
Registry
ClinicalTrials.gov
Start date
10 June 2025
Est. completion
1 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Patients with Dose Limiting Toxicity

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: 28 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