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

  • STATUS
    Recruiting
  • End date
    Dec 13, 2024
  • participants needed
    72
  • sponsor
    Taiga Biotechnologies, Inc.
Updated on 13 May 2022
platelet count
renal function
absolute neutrophil count
gilbert's syndrome
metastasis
liver metastasis

Summary

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.

Details
Condition Stage III Melanoma, Stage IV Melanoma
Treatment TBX-3400
Clinical Study IdentifierNCT03385486
SponsorTaiga Biotechnologies, Inc.
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

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
Male or female patients age 18 or older
malignant melanoma
Measurable or evaluable disease by RECIST version 1.1
Previously treated with checkpoint inhibitor therapy either alone or in combination
Capable of understanding and complying with protocol requirements
with either stable disease or progressive disease per RECIST version 1.1 (there is no
A life expectancy of greater than 24 weeks at Screening
minimum treatment duration for patients who have progressive disease while on
checkpoint inhibitor therapy)
ECOG Performance Status of 0 to 2
Adequate bone marrow, liver, and renal function as defined below
Written informed consent from the patient or the patient's legally acceptable
representative prior to the initiation of any study procedures
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

Pregnant or breast feeding
Presence of Hepatitis B and/or Hepatitis C active infection
Patients who meet any of the following criteria will not be eligible for participation in
the study
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
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
Symptomatic congestive heart failure, defined as New York Heart Association Class II
or higher
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