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CAR T-cell Therapy

CATCH T Cells for Solid Cancers

Phase 1

Recruiting

Led By Tannaz Armaghany, 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

Lansky or Karnofsky score ≥ 60%

platelet count > 25,000/μl (can be transfused)

Must not have

Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)

Uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Summary

This trial is testing a new way to fight cancer by genetically engineering patients' T cells to better target and kill their tumor cells.

Who is the study for?

Adults with certain solid tumors like liver cancer, who have tried standard treatments without success or can't receive them. They must be in relatively good health with a life expectancy of at least 12 weeks and adequate organ function. Pregnant individuals, those with HIV, active infections (except Hepatitis B/C), or history of organ transplant cannot participate.Check my eligibility

What is being tested?

The trial is testing CATCH T cells, which are the patient's own immune cells genetically modified to target and kill cancer cells by recognizing a protein called GPC3 on tumor surfaces. The study aims to determine the highest safe dose, how long these cells last in the body, their side effects, and effectiveness against GPC3-positive tumors.See study design

What are the potential side effects?

Potential side effects include reactions related to immune response such as fever or fatigue; risk of infection; possible damage to non-cancerous tissues that also carry the GPC3 protein; and other unforeseen complications due to genetic modification of T cells.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may need occasional help.

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My platelet count is above 25,000, or I can receive a transfusion to reach it.

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I can care for myself but may need occasional help.

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My kidneys are functioning well, with a creatinine clearance rate of 60 ml/min or higher.

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My liver is functioning well enough for treatment.

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My condition did not improve after initial and at least one follow-up treatment.

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I am 18 years old or older.

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My tumor is GPC3-positive and has relapsed or is not responding to treatment.

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I am 18 years old or older.

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I have recovered from the side effects of my previous cancer treatments.

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My bilirubin levels are less than three times the upper limit.

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My liver cancer is at an early to intermediate stage.

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My liver is functioning well enough for treatment.

Exclusion Criteria

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

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I do not have any active infections, except possibly Hepatitis B or C.

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I do not have any infections that are not responding to treatment.

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I am allergic to mouse protein products or have human anti-mouse antibodies.

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I have had an organ transplant.

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 response or partial response

Trial Design

1Treatment groups

Experimental Treatment

Group I: CATCH T cellsExperimental Treatment1 Intervention

GPC3-CAR and the IL15 (CATCH T cells) will be administered to patients with GPC3-positive solid tumors.

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,006 Previous Clinical Trials

6,003,281 Total Patients Enrolled

3 Trials studying Wilms Tumor

69 Patients Enrolled for Wilms Tumor

The Methodist Hospital Research InstituteOTHER

275 Previous Clinical Trials

80,510 Total Patients Enrolled

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,796 Total Patients Enrolled

3 Trials studying Wilms Tumor

69 Patients Enrolled for Wilms Tumor

Media Library

CATCH T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05103631 — Phase 1

Wilms Tumor Research Study Groups: CATCH T cells

Wilms Tumor Clinical Trial 2023: CATCH T cells Highlights & Side Effects. Trial Name: NCT05103631 — Phase 1

CATCH T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103631 — Phase 1

~3 spots leftby Jan 2025

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