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CAR-GPC3 T Cell Therapy for Cancer (DUET-1 Trial)
DUET-1 Trial Summary
This trial will test a new cancer treatment in humans for the first time to see if it is safe, and to find the best dose. The trial is for people with a certain type of cancer who have not responded to other treatments.
DUET-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDUET-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DUET-1 Trial Design
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Who is running the clinical trial?
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- My cancer is advanced, cannot be surgically removed, and tests show high levels of GPC3.My liver cancer is not fibrolamellar or mixed hepatocellular cholangiocarcinoma.I may have had radiation for symptom relief or hormone treatment, but it's been over a week since.I do not have moderate or severe fluid buildup in my abdomen.I have a heart condition that affects my daily life.I do not have severe diseases like uncontrolled bleeding, serious infections, or active hepatitis.I have completed the required waiting period after my last cancer treatment before starting a new one.I can provide a recent tumor sample for testing.I have untreated brain tumors or metastasis.My liver is functioning well despite having liver cancer.I have liver cancer with at least 2 areas affected, including one that can be measured.I have had a stem cell transplant from a donor.I have recovered from side effects of previous treatments to my normal health level or almost.I am fully active or can carry out light work.I haven't had a severe cancer needing treatment in the last 3 years.I am between 18 and 80 years old.My body weight is 50kg or more.I am on medication for an autoimmune disease.My condition worsened or didn't respond well to standard treatments.I have waited the required time after my last cancer treatment before starting a new one.I won't start any new cancer treatments except for pain relief radiation or hormone therapy during the study.My kidney, liver, and lung functions are all within normal ranges.I do not have any active infections, except for controlled HIV.I have previously undergone a cell therapy treatment.
- Group 1: GPC3+ solid tumors
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any eligibility requirements for being a participant in this medical trial?
"The inclusion criteria for this research requires participants to have carcinoma and hepatocellular, in addition to being between 18-80 years old. Currently, the team is looking to recruit nearly one hundred individuals."
Is enrollment open to those aged 60 or more in this clinical investigation?
"The range of ages for this medical trial is between 18 and 80, as indicated by the eligibility requirements."
Is enrollment for this clinical trial still available?
"Clinicaltrials.gov has confirmed that this trial is actively seeking suitable participants. The study was first published on May 18th 2022 and the most recent amendment to its details were made October 31st 2022."
How many participants have been included in this research endeavor?
"Affirmative. A glance at clinicaltrials.gov shows that this medical research, which was initially posted on May 18th 2022, is in the process of recruiting participants. 98 individuals must be enrolled from 3 separate sites for the study to reach its desired sample size."
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