Clinical Trials /

Study of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors

NCT03385486

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors
  • Official Title: A Phase 1 Single-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

Clinical Trial IDs

  • ORG STUDY ID: TBX-3400-001
  • NCT ID: NCT03385486

Conditions

  • Stage III Melanoma
  • Stage IV Melanoma

Interventions

DrugSynonymsArms
TBX-3400TBX-3400

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TBX-3400ExperimentalTBX-3400 by intravenous infusion
  • TBX-3400

Eligibility Criteria

        Inclusion Criteria:

        Patients must meet all of the following inclusion criteria to be eligible for participation
        in the study:

          1. Histopathologically confirmed diagnosis of advanced, unresectable or metastatic
             malignant melanoma

          2. Male or female patients age 18 or older

          3. 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)

          4. Measurable or evaluable disease by RECIST version 1.1

          5. Capable of understanding and complying with protocol requirements

          6. A life expectancy of greater than 24 weeks at Screening

          7. ECOG Performance Status of 0 to 2

          8. Written informed consent from the patient or the patient's legally acceptable
             representative prior to the initiation of any study procedures

          9. 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:

          1. Pregnant or breast feeding

          2. Developed immune-related toxicity while on prior checkpoint inhibitor therapy that has
             not yet returned to Grade 1 or better

          3. 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

          4. 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

          5. 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

          6. Severe uncontrolled cardiac disease within 3 months of study entry, including unstable
             or new onset angina, myocardial infarction or cerebrovascular accident

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

          8. 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

          9. Symptomatic congestive heart failure, defined as New York Heart Association Class II
             or higher
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Adverse events from subject reporting

Secondary Outcome Measures

Measure:Tumor responses as defined by RECIST version 1.1
Time Frame:26 months
Safety Issue:
Description:Tumor measurements to assess disease state
Measure:Tumor responses as defined by irRECIST
Time Frame:26 months
Safety Issue:
Description:Tumor measurements to assess disease state
Measure:Assessment of concentrations of certain chemokines, such as cluster of differentiation 69 (CD69), as biomarkers of activity of TBX-3400
Time Frame:26 months
Safety Issue:
Description:Preliminary efficacy assessment to measure activity of TBX-3400
Measure:Presence and/or concentration of anti TBX-3400 antibodies
Time Frame:26 months
Safety Issue:
Description:Measure of immunogenicity of TBX-3400

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Taiga Biotechnologies, Inc.

Trial Keywords

  • Melanoma
  • Resistant
  • Refractory

Last Updated

September 18, 2019