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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I understand and can follow the study's requirements.
Select...
I can care for myself and am up and about more than half of my waking hours.
Select...
My melanoma cannot be removed by surgery and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
+1 moreOther outcome measures
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
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TBX-3400Experimental Treatment1 Intervention
TBX-3400 by intravenous infusion
Find a Location
Who is running the clinical trial?
Taiga Biotechnologies, Inc.Lead Sponsor
3 Previous Clinical Trials
78 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand and can follow the study's requirements.I have heart failure symptoms that affect my daily activities.I am taking high doses of steroids, more than 10 mg/day of prednisone.I am a woman who can have children and do not use birth control.I am 18 years old or older.I experienced side effects from immune therapy that haven't improved.I have brain metastases that have been treated, and I've been stable without steroids for over a week.I haven't had severe heart issues like a heart attack or stroke in the last 3 months.My HIV is not well-controlled, with over 400 copies/mL.I've had treatment with checkpoint inhibitors for my cancer, regardless of the outcome.I can care for myself and am up and about more than half of my waking hours.My blood, liver, and kidney functions meet the required levels for the study.My melanoma cannot be removed by surgery and has spread.You have an active Hepatitis B or Hepatitis C infection.You are expected to live for more than 24 weeks from the time of screening.Your disease can be measured or evaluated using specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: TBX-3400
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the accepted capacity of participants for this medical experiment?
"Affirmative. Research hosted on clinicaltrials.gov corroborates that this scientific investigation, which was first advertised on June 2nd 2019, is actively recruiting participants. Approximately 72 individuals need to be enrolled from two separate healthcare facilities."
Answered by AI
What detrimental effects could arise from taking TBX-3400?
"Due to a lack of data on TBX-3400, our team has assigned it a safety rating of 1. This is because the drug is currently being assessed through Phase 1 trials and therefore its efficacy and safety have yet to be established."
Answered by AI
Are there still openings for participants in this experiment?
"Confirmed. As listed on clinicaltrials.gov, this scientific trial is actively enrolling individuals; it was initially posted on June 2nd 2019 and updated most recently on May 1st 2022. The total number of participants to be recruited across two sites stands at 72 in sum."
Answered by AI
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