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.
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 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
Clinical Trial IDs
- ORG STUDY ID:
TBX-3400-001
- NCT ID:
NCT03385486
Conditions
- Stage III Melanoma
- Stage IV Melanoma
Interventions
Drug | Synonyms | Arms |
---|
TBX-3400 | | TBX-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
Name | Type | Description | Interventions |
---|
TBX-3400 | Experimental | TBX-3400 by intravenous infusion | |
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. Presence of Hepatitis B and/or Hepatitis C active infection
10. 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
January 5, 2021