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CAR T-cell Therapy
CAR-GPC3 T Cell Therapy for Cancer (DUET-1 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Sotio Biotech Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed advanced unresectable or metastatic hepatocellular carcinoma (HCC), squamous cell carcinoma (SCC) of the lung, myxoid/round cell liposarcoma (MRCLS), or Merkel cell carcinoma (MCC) with GPC3 overexpression by IHC
No fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma histology for subjects with HCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of response for patients with response (complete or partial) until disease progression or death, whichever came first, assessed up to approximately 15 years
Awards & highlights
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.
Who is the study for?
Adults aged 18-80 with advanced solid tumors positive for GPC3, such as liver cancer or lung squamous cell carcinoma. They must have a life expectancy over 16 weeks, good organ function, and no severe complications like major untreated brain metastasis. Women of childbearing age and men with partners must agree to effective contraception.Check my eligibility
What is being tested?
The trial is testing BOXR1030 T Cells after chemotherapy in patients with GPC3-positive tumors. It's the first time this treatment is being used on humans (Phase 1), aiming to find the safest dose for Phase 2 trials while monitoring its safety across multiple centers.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions related to immune therapies such as CAR-T cells: fever, fatigue, immune system reactions, and possible organ inflammation due to an aggressive immune response.
DUET-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, and tests show high levels of GPC3.
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My liver cancer is not fibrolamellar or mixed hepatocellular cholangiocarcinoma.
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I do not have moderate or severe fluid buildup in my abdomen.
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I have completed the required waiting period after my last cancer treatment before starting a new one.
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My liver is functioning well despite having liver cancer.
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I have liver cancer with at least 2 areas affected, including one that can be measured.
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I am fully active or can carry out light work.
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I am between 18 and 80 years old.
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My body weight is 50kg or more.
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My condition worsened or didn't respond well to standard treatments.
DUET-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of response for patients with response (complete or partial) until disease progression or death, whichever came first, assessed up to approximately 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of response for patients with response (complete or partial) until disease progression or death, whichever came first, assessed up to approximately 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity
MTD
RP2D
+1 moreSecondary outcome measures
BOXR1030 T-cell characterization in blood
BOXR1030 T-cell levels in blood
Best overall response
+7 moreDUET-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: GPC3+ solid tumorsExperimental Treatment1 Intervention
One time intravenous administration of BOXR1030 after completion of cyclophosphamide and fludarabine LD chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAR-GPC3 T Cells
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Sotio Biotech Inc.Lead Sponsor
1 Previous Clinical Trials
269 Total Patients Enrolled
SOTIO Biotech a.s.Industry Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
SOTIO Biotech AGIndustry Sponsor
4 Previous Clinical Trials
612 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: GPC3+ solid tumors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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