- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03385486
Study of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors
A Phase 1 Multi-Center Dose-Escalation Study of the Safety, Tolerability and Early Efficacy of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors
This is a study of transfusion of TBX-3400 in patients with stage III and IV melanoma resistant or refractory to Immune Checkpoint Inhibitors.
The patient's own blood cells are exposed to a protein that has been shown in the laboratory to result in anti-tumor activity.
The study hypothesis is that TBX-3400 cells will enhance anti-tumor activity and improve the body's immune response.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Yosef Refaeli, PhD
- Phone Number: +1-720-859-3547
- Email: refaeli@taigabiotech.com
Study Contact Backup
- Name: Vivienne Margolis
- Phone Number: +972-52-463-9634
- Email: vmargolis@taigabiotech.com
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Recruiting
- The Angeles Clinic and Research Institute
-
Contact:
- Dr. Inderjit Mehmi, MD
- Phone Number: 310-294-0438
- Email: imehmi@theangelesclinic.org
-
-
Colorado
-
Denver, Colorado, United States, 80045
- Recruiting
- University of Colorado Cancer Center
-
Contact:
- Theresa Medina, MD
- Phone Number: 720-848-7135
- Email: Theresa.Medina@ucdenver.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for participation in the study:
- Histopathologically confirmed diagnosis of advanced, unresectable or metastatic malignant melanoma
- Male or female patients age 18 or older
- Previously treated with checkpoint inhibitor therapy either alone or in combination with either stable disease or progressive disease per RECIST version 1.1 (there is no minimum treatment duration for patients who have progressive disease while on checkpoint inhibitor therapy)
- Measurable or evaluable disease by RECIST version 1.1
- Capable of understanding and complying with protocol requirements
- A life expectancy of greater than 24 weeks at Screening
- ECOG Performance Status of 0 to 2
- Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study procedures
Adequate bone marrow, liver, and renal function as defined below:
- hemoglobin ≥8.0 g/dL (transfusions allowed)
- absolute neutrophil count ≥1500/µL
- platelet count ≥100,000/µL (transfusions allowed)
- alanine transaminase and aspartate transaminase ≤3.0 times the upper limit of normal (ULN), or ≤5 times ULN for patients with known hepatic metastases
- total serum bilirubin ≤1.5 x the ULN; ≤2.0 x the ULN if liver metastases are present; patients with a known history of Gilbert's syndrome (≤3.0 x the ULN) and/or isolated elevations of indirect bilirubin are eligible for study participation
- estimated glomerular filtration rate ≥50 mL/min/1.73 m^2 (using Cockcroft Gault formula)
Exclusion Criteria:
Patients who meet any of the following criteria will not be eligible for participation in the study:
- Pregnant or breast feeding
- Developed immune-related toxicity while on prior checkpoint inhibitor therapy that has not yet returned to Grade 1 or better
- Require systemic pharmacologic doses of corticosteroids at or above the equivalent of 10 mg/day of prednisone; replacement doses, topical, ophthalmologic and inhalational steroids are permitted
- Active, symptomatic central nervous system (CNS) metastases. Patients with CNS metastases are eligible for the trial if the metastases have been treated by surgery and/or radiotherapy and the patient is off corticosteroids and is neurologically stable for at least 7 days prior to screening
- Any concurrent uncontrolled illness, including mental illness or substance abuse which in the opinion of the investigator would make the patient unable to cooperate or participate in the trial
- Severe uncontrolled cardiac disease within 3 months of study entry, including unstable or new onset angina, myocardial infarction or cerebrovascular accident
- Women of childbearing potential who are unable or unwilling to use an acceptable method of contraception
- Known infection with human immunodeficiency virus (HIV) that is not well controlled on anti-retroviral therapy as defined by HIV RNA more than 400 copies/mL or severely symptomatic
- Presence of Hepatitis B and/or Hepatitis C active infection
- Symptomatic congestive heart failure, defined as New York Heart Association Class II or higher
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TBX-3400
TBX-3400 by intravenous infusion
|
Autologous transfusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 26 months
|
Adverse events from subject reporting
|
26 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor responses as defined by RECIST version 1.1
Time Frame: 26 months
|
Tumor measurements to assess disease state
|
26 months
|
Tumor responses as defined by irRECIST
Time Frame: 26 months
|
Tumor measurements to assess disease state
|
26 months
|
Assessment of concentrations of certain chemokines, such as cluster of differentiation 69 (CD69), as biomarkers of activity of TBX-3400
Time Frame: 26 months
|
Preliminary efficacy assessment to measure activity of TBX-3400
|
26 months
|
Presence and/or concentration of anti TBX-3400 antibodies
Time Frame: 26 months
|
Measure of immunogenicity of TBX-3400
|
26 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantification of the concentration of interleukin-1 (IL-1) in plasma
Time Frame: 26 months
|
Preliminary efficacy assessment to measure activity of TBX-3400
|
26 months
|
Quantification of the concentration of interleukin-6 (IL-6) in plasma
Time Frame: 26 months
|
Preliminary efficacy assessment to measure activity of TBX-3400
|
26 months
|
Quantification of the concentration of interferon-alpha (INF-α) in plasma
Time Frame: 26 months
|
Preliminary efficacy assessment to measure activity of TBX-3400
|
26 months
|
Quantification of the concentration of interferon gamma inducible protein 10 kD (IP-10) in plasma
Time Frame: 26 months
|
Preliminary efficacy assessment to measure activity of TBX-3400
|
26 months
|
Quantification of the concentration of interferon-gamma (IFN-γ) in plasma
Time Frame: 26 months
|
Preliminary efficacy assessment to measure activity of TBX-3400
|
26 months
|
Quantification of the concentration of transforming growth factor-beta (TGF-ß) in plasma
Time Frame: 26 months
|
Preliminary efficacy assessment to measure activity of TBX-3400
|
26 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBX-3400-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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