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NCT05103631 · ClinicalTrials.gov registry record · Phase 1

Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells for Solid Tumors

A Phase 1 study of Solid Tumor and Rhabdomyosarcoma, sponsored by Baylor College of Medicine.

Active
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT05103631: Active Phase 1 study of Solid Tumor and Rhabdomyosarcoma, sponsored by Baylor College of Medicine.

NCT05103631 is a Phase 1 study of Solid Tumor and Rhabdomyosarcoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 12 participants, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05103631, a Phase 1 study of Solid Tumor and Rhabdomyosarcoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CATCH T cells, a new experimental treatment. 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. Investigators have found from previous research that we can put a new gene (a tiny part of what makes-up DNA and carriesa person's traits) into T cells that will make them recognize cancer cells and kill them . In the lab, we made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33. The antibody GC33 recognizes a protein called GPC3 that is found on the hepatocellular carcinoma the patient has. The specific CAR we are making is called GPC3-CAR. To make this CAR more effective, we also added a gene encoding protein called IL15. This protein helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL 15. This study will test T cells that we have made with CATCH T cells in patients with GPC3-positive solid tumors such as the ones participating in this study. T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The investigators will insert the iCasp9 and IL15

Primary Outcome

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 dose-limiting toxicity is any Grade 3 or Grade 4 nonhematologic toxicity that fails to return to Grade 2 within 72 hours; Grade 2 to 4 allergic reaction to CAR T cell infusion; Grade 4 hematologic toxicity that persists for 28 days or greater; Grade 3 and 4 expected reactions due to CRS and neurotoxicity are seen with the us

Interventions

  • GENETIC CATCH T cells

Study Locations (1)

Texas

  • Houston Methodist Hospital - Houston

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2021-06-17
Est. Completion 2040-12
Phase Phase 1
Baylor College of Medicine

616 total trials

What the registry record for NCT05103631 still lists

NCT05103631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (95% lower).

The record links to 8 conditions, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which CATCH T cells is the first listed.

NCT05103631 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT05103631 about?

NCT05103631 is a clinical study titled "Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells for Solid Tumors". Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CATCH T cells, a new experimental treatment. The body has different ways of fighting infec...

What is the current status of trial NCT05103631?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-06-17. Estimated completion is 2040-12.

What conditions does trial NCT05103631 study?

This clinical trial studies the following conditions: Solid Tumor, Rhabdomyosarcoma, Wilms Tumor, Liposarcoma, Malignant Rhabdoid Tumor.

What interventions are being tested in trial NCT05103631?

The interventions under investigation include: CATCH T cells (GENETIC).

Who is sponsoring clinical trial NCT05103631?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05103631 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05103631's enrollment target sits among peer trials

12 190th of 196 higher than 4 of 196 other Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05103631, the US trial registry maintained by the National Library of Medicine. NCT05103631 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.