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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06198296
Other study ID # H-54859 Co-EXIST
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date January 1, 2026
Est. completion date February 1, 2043

Study information

Verified date December 2023
Source Baylor College of Medicine
Contact Andras Heczey, MD
Phone (832) 822-4242
Email heczey@bcm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. In order to get them to kill cancers more effectively, in the laboratory, the study team inserted a new gene called a chimeric antigen receptor (CAR) into T cells that makes them recognize cancer cells and kill them. When inserted, this new CAR T cell can specifically recognize a protein found on solid tumors, called glypican-3 (GPC3). To make this GPC3-CAR more effective, the study team also added two genes called IL15 and IL21 that help CAR T cells grow better and stay in the blood longer so that they may kill tumors better. When the study team did this in the laboratory, they found that this mixture of GPC3-CAR,IL15 and IL21 killed tumor cells better when compared with CAR T cells that did not have IL15 plus IL21 in the laboratory. This study will use those cells, which are called 21.15.GPC3-CAR T cells, to treat patients with solid tumors that have GPC3 on their surface. The study team also wanted to make sure that they could stop the 21.15.GPC3-CAR T cells from growing in the blood should there be any bad side effects. In order to do so, they inserted a gene called iCasp9 into the FAST-CAR T cells. This allows us the elimination of 21.15.GPC3-CAR T cells in the blood when the gene comes into contact with a medication called AP1903. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. This drug will only be used to kill the T cells if necessary due to side effects . The study team has treated patients with T cells that include GPC3. Patients have also been treated with IL-21 and with IL-15. Patients have not been treated with a combination of T cells that contain GPC3, IL-21 and IL-15. To summarize, this study will test the effect of 21.15.GPC3-CAR T cells in patients with solid tumors that express GPC3 on their surface. The 21.15.GPC3-CAR T cells are an investigational product not yet approved by the Food and Drug Administration.


Description:

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Study Design


Intervention

Genetic:
21.15.GPC3-CAR T cells
Three different dosing schedules will be evaluated. The following dose levels will be evaluated: The following dose levels will be evaluated: DL0: 3x10^7/m2 DL1: 1x10^8/m2 DL2: 3x10^8/m2 DL3: 1x10^9/m2

Locations

Country Name City State
United States Houston Methodist Hospital Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor College of Medicine Center for Cell and Gene Therapy, Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients with Dose Limiting Toxicity A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-CAR T cells. Specifically those which are Grade 5; non-hematologic Grade 3-4 not returning to Grade 2 within 72 hours; Grade 2-4 allergic reaction; Hematologic Grade 4 that fails to return to Grade 2 or baseline (whichever is more severe) within 14 days; all grade 4 CRS and neurologic toxicities and grade 3 CRS and neurologic toxicities that fail to return to Grade 1 within 7 days 4 weeks
Secondary Percent of Patients with best response as either complete remission or partial remission Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the two patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate 4 weeks
Secondary Median T cell persistence T cell persistence will be measured by PCR 15 years
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