This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.
Signed and dated informed consent form.
Male or female, > 18 years old.
Minimum body weight of 50 kilograms (kg).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day 1.
Major surgery, except for vascular access placement, within the 30 days prior to study Day 1.
Active autoimmune disease requiring immunosuppressive therapy.
Infection requiring systemic treatment within 30 days prior to study Day 1.
Sequential
KB-GDT-01
Biological/VaccineKB-GDT-01 is an allogeneic, gamma delta T-cell suspension product manufactured from the isolation of healthy donor peripheral blood mononuclear cells (PBMC). The KB-GDT-01 cells are cryopreserved in vapor phase liquid nitrogen (LN2) in 50 mL CryoMACS® cryobags for a total of 200 × 106 viable cells/bag. The KB-GDT-01 cryopreserved product is thawed and administered intravenously (IV) until the entire bag is infused by gravity. Low dose radiotherapy (LDRT) will be administered to selected tumor sites (maximum of 5 isocenters) at 1.0 Gy/fraction on Days 1 and 2, followed by the KB-GDT-01 IV infusion on Day 3. LDRT will be repeated on Days 8 and 9, and the 2nd KB-GDT-01 IV infusion on Day 10.
Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
DLT, defined as the occurrence or start of a clinically significant Grade 3 or greater AE (per CTCAE v5.0) occurring during the DLT assessment period that cannot be attributed to disease progression, intercurrent illness, or concomitant medication.
Objective Response Rate (ORR)
Investigator assessed ORR per RECIST v1.1. ORR is defined as the percentage of participants with a best overall response of complete or partial response.
Progression Free Survival (PFS)
Investigator assessed PFS per RECIST v1.1. PFS is defined as the time from first study drug infusion until the first evidence of disease progression or death.
Overall Survival (OS)
Investigator assessed OS per RECIST v1.1. OS is defined as the time from first study drug infusion to death.
Time to Progression (TTP)
Investigator assessed TTP per RECIST v1.1. TTP is defined as the time from first study drug infusion until first evidence of disease progression.
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Kiromic BioPharma Inc.
Lead sponsor
Stiris Research Inc
Collaborator
