← Back to Search

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

Must not have

Clinically significant (i.e., active) cardiovascular disease

Uncontrolled or life-threatening symptomatic concomitant disease including clinically significant gastrointestinal bleeding or pulmonary hemorrhage within 4 weeks before screening, known symptomatic human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months prior to screening, or a current CD4 count <350 cells/µL, symptomatic active hepatitis B or C checked at screening, or active tuberculosis therapy

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is advanced, cannot be surgically removed, and tests show high levels of GPC3.

Select...

My liver cancer is not fibrolamellar or mixed hepatocellular cholangiocarcinoma.

Select...

I do not have moderate or severe fluid buildup in my abdomen.

Select...

I have completed the required waiting period after my last cancer treatment before starting a new one.

Select...

My liver is functioning well despite having liver cancer.

Select...

I have liver cancer with at least 2 areas affected, including one that can be measured.

Select...

I am fully active or can carry out light work.

Select...

I am between 18 and 80 years old.

Select...

My body weight is 50kg or more.

Select...

My condition worsened or didn't respond well to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a heart condition that affects my daily life.

Select...

I do not have severe diseases like uncontrolled bleeding, serious infections, or active hepatitis.

Select...

I have untreated brain tumors or metastasis.

Select...

I have had a stem cell transplant from a donor.

Select...

I haven't had a severe cancer needing treatment in the last 3 years.

Select...

I am on medication for an autoimmune disease.

Select...

I won't start any new cancer treatments except for pain relief radiation or hormone therapy during the study.

Select...

I do not have any active infections, except for controlled HIV.

Select...

I have previously undergone a cell therapy treatment.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.