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CAR T-cell Therapy

21.15.GPC3-CAR T cells for Wilms Tumor

Phase 1

Waitlist Available

Led By David Steffin, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥21 years

Lansky or Karnofsky score ≥60%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is testing a new treatment for solid tumors that combines antibodies and T cells. Antibodies are proteins that help protect the body from diseases, including cancer. T cells are special blood cells that can

Who is the study for?

Adults with certain solid tumors that test positive for a protein called GPC3 can join this trial. They should be at least 21 years old, have a reasonable quality of life score, and expect to live at least another 16 weeks. People with liver cancer must meet specific criteria related to their disease stage and liver function.Check my eligibility

What is being tested?

The trial is testing a new type of T cell therapy called 21.15.GPC3-CAR T cells designed to target and kill tumor cells in adults with GPC3-positive solid tumors. These engineered T cells also carry genes that help them grow better and last longer in the body.See study design

What are the potential side effects?

Potential side effects may include reactions from the engineered T cells such as fever, fatigue, or an overactive immune response which could affect normal organs. The study includes safety measures like using AP1903 drug if needed to stop the CAR T cells.

Eligibility Criteria

Inclusion Criteria

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

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I am 21 years old or older.

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I can care for myself but may need occasional help.

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My liver cancer is at an early to intermediate stage.

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My tumor is GPC3-positive according to specific tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients with Dose Limiting Toxicity

Secondary outcome measures

Median T cell persistence

Percent of Patients with best response as either complete remission or partial remission

Trial Design

1Treatment groups

Experimental Treatment

Group I: 21.15.GPC3-CAR T cellsExperimental Treatment1 Intervention

GPC3-CAR and the IL15 plus IL21 will be administered to patients with GPC3-positive solid tumors.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,796 Total Patients Enrolled

3 Trials studying Wilms Tumor

75 Patients Enrolled for Wilms Tumor

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,931 Total Patients Enrolled

3 Trials studying Wilms Tumor

75 Patients Enrolled for Wilms Tumor

David Steffin, MDPrincipal InvestigatorBaylor College of Medicine

2 Previous Clinical Trials

48 Total Patients Enrolled

2 Trials studying Wilms Tumor

48 Patients Enrolled for Wilms Tumor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being accepted for enrollment in this clinical trial?

"According to the information available on clinicaltrials.gov, this particular clinical trial is no longer actively seeking participants. The trial was initially posted on January 1st, 2026 and underwent its most recent update on December 27th, 2023. However, it's worth noting that there are currently 2908 other ongoing studies actively recruiting participants at this time."

Answered by AI

What is the level of safety associated with administering 21.15.GPC3-CAR T cells to individuals?

"Based on the phase of this trial (Phase 1), our team at Power rates the safety of 21.15.GPC3-CAR T cells as a score of 1 due to limited data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells

Andras Heczey 2026. "Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06198296.

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