Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age16-80
SponsorM.D. Anderson Cancer Center
About this trial
The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with all cancer histology, with an HLA-A*02:01, HLA-A*02:05 or HLA-A*02:06 positive and a positive expression of NY-ESO-1 (>/= 50% tumor cells 2+ or 3+ by IHC) in the preenrollment tumor sample, for the dose escalation cohort. NY-ESO expression must be confirmed at MDACC prior to study entry.
Patients with histologically confirmed synovial sarcoma (cohort 1) or myxoid/round cell liposarcoma (cohort 2), with an HLA-A*02:01, HLA-A*02:05 or HLA-A*02:06 positive and a positive expression of NY-ESO-1 (>/= 50% tumor cells 2+ or 3+ by IHC) in the pre-enrollment tumor sample, for the expansion cohorts. Archival samples will be permitted for screening. NY-ESO expression must be confirmed at MDACC prior to study entry.
Patients must meet disease-specific eligibility criteria (see below).
Patients must have relapsed or become refractory to standard of care treatment and must have received at least one prior line of systemic therapy including either doxorubicin and/or ifosfamide (synovial sarcoma and MRCLS) or trabectedin (MRCLS).
Disqualifiers
Presence of clinically significant ≥ Grade 2 toxicity from previous anticancer treatment, as determined by the PI.
Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note: Patients with simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
Known Active hepatitis B or C.
Known human immunodeficiency virus with detectable viral load.
Trial design
Design model
Single group
Treatments tested in this trial
Fludarabine phosphate
DrugGiven by IV (vein)
NY-ESO-1 TCR/IL-15 NK
DrugGiven by IV (vein)
Cyclophosphamide
DrugGiven by IV (vein)
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Dose escalation - Inpatient and OutpatientExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov