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CAR T-cell Therapy

TBX-3400 for Advanced Melanoma

Phase 1

Recruiting

Research Sponsored by Taiga Biotechnologies, Inc.

Eligibility Criteria Checklist

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

Must have

Capable of understanding and complying with protocol requirements

ECOG Performance Status of 0 to 2

Must not have

Symptomatic congestive heart failure, defined as New York Heart Association Class II or higher

Women of childbearing potential who are unable or unwilling to use an acceptable method of contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment for melanoma that has spread and is not responding to other treatments. In this treatment, the patient's own blood cells are exposed to a protein that has been shown to kill tumor cells in the laboratory. The hypothesis is that this will help the patient's immune system to better fight the cancer.

Who is the study for?

This trial is for adults with advanced melanoma that hasn't responded to immune checkpoint inhibitors. Participants must have good organ function, understand the study, and not be pregnant or have severe illnesses or uncontrolled infections. They should have a life expectancy over 24 weeks and an ECOG Performance Status of 0 to 2.

What is being tested?

The trial tests TBX-3400, where patients' blood cells are treated with a protein to boost anti-tumor effects and improve immune response against stage III/IV melanoma resistant to standard treatments.

What are the potential side effects?

Potential side effects aren't specified here but may include reactions related to the immune system's enhancement and typical risks associated with transfusions such as fever, allergic reactions, or infection.

Eligibility Criteria

Inclusion Criteria

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

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I understand and can follow the study's requirements.

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I can care for myself and am up and about more than half of my waking hours.

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My melanoma cannot be removed by surgery and has spread.

Exclusion Criteria

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

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I have heart failure symptoms that affect my daily activities.

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I am a woman who can have children and do not use birth control.

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I experienced side effects from immune therapy that haven't improved.

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My HIV is not well-controlled, with over 400 copies/mL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of treatment-emergent adverse events (TEAEs), including the incidence of dose-limiting toxicities (DLTs), graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Secondary study objectives

Assessment of concentrations of certain chemokines, such as cluster of differentiation 69 (CD69), as biomarkers of activity of TBX-3400

Presence and/or concentration of anti TBX-3400 antibodies

Tumor responses as defined by RECIST version 1.1

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Other study objectives

Quantification of the concentration of interferon gamma inducible protein 10 kD (IP-10) in plasma

Quantification of the concentration of interferon-alpha (INF-α) in plasma

Quantification of the concentration of interferon-gamma (IFN-γ) in plasma

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