Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
study ends around
Principal Investigator
by Miguel Angel Villalona

Description

Summary

This is a Phase 1 dose escalation clinical trial determining the maximum tolerated dose of NK-102 in subjects with advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC) (previously treated with PD1 and/or PD-L1 immune checkpoint inhibitors) as monotherapy or in combination with atezolizumab.

Official Title

Phase I Trial of Umbilical Cord Blood Natural Killer Cells (CB-NK) Expressing Soluble IL-15 (sIL-15) and PD-L1 +/- Atezolizumab in Non-Small Cell Lung Cancer Patients Refractory to PD-1/PD-L1 Immune Checkpoint Inhibitors

Keywords

Non-small Cell Lung Cancer, NSCLC, Lung Cancer, Non-small Cell, Lung Cancer, Cord Blood Natural Killer Cells, CB-NK, Atezolizumab, Lung Neoplasms, Non-Small-Cell Lung Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • Documented informed consent of the participant
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • Age: ≥ 18 years
  • ECOG 0 to 1
  • NSCLC patients with advanced, metastatic, or recurrent disease, previously treated with a PD-1 or PDL-1 immune checkpoint inhibitor, either as single agent or in combination with chemotherapy or other immunotherapy or experimental agents
  • Radiographically demonstrated tumor progression on or after PD-1/PD-L1 immune checkpoint inhibitor treatment
  • Preserved organ function and recovery of prior drug related toxicities (except alopecia or grade 2 anemia) to grade 1 or better
  • No cytotoxic chemotherapy or immunotherapy over the three weeks prior to lymphodepletion
  • Histologically confirmed Non-Small Cell Lung Cancer
  • Measurable disease as per RECIST criteria 1.1
  • Fully recovered from the acute toxic effects (except alopecia) to ≤ Grade 1 to prior anti- cancer therapy
  • Cardiac ejection fraction ≥ 50% and no clinically significant EKG findings (same criteria must also be met for patients selected for a second course of therapy).
  • ANC ≥ 1,500/mm3
  • Hgb ≥ 8 g/dl
  • Platelets ≥ 100,000/mm3
  • Total bilirubin ≤ 1.5 X ULN
  • AST ≤ 1.5 x ULN
  • ALT ≤ 1.5 x ULN
  • AP ≤ 1.5 x ULN
  • Creatinine within 1.5 times the normal upper limit or with a creatinine clearance of ≥ 50 mL/min per 24-hour urine test or the Cockcroft-Gault formula
  • If not receiving anticoagulants: International Normalized Ratio (INR) OR Prothrombin (PT) ≤ 1.5 x ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
  • Seronegative for HIV Ag/Ab combo, HCV*, active HBV (Surface Antigen Negative)

    *If positive, Hepatitis C RNA quantitation must be performed.

  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 06 months after the last dose of protocol therapy.
    • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only).

You CAN'T join if...

  • Autologous stem cell transplant within 1 year prior to Day 1 of protocol therapy
  • Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to Day 1 of protocol therapy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
  • Active diarrhea
  • Clinically significant uncontrolled illness
  • Active infection requiring antibiotics
  • Known history and/or positive serology for immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
  • Diagnosis of Gilbert's disease
  • Other active malignancy
  • Females only: Pregnant or breastfeeding
  • Severe (grade 3 or higher) immune related adverse events during prior PD-1 inhibitor treatment
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
  • Concomitant use of other investigational agents
  • Patients with EGFR mutations or ALK translocations in their tumors, unless treatment with the indicated tyrosine kinase inhibitor has failed
  • Active brain metastases. Previously treated brain metastasis must demonstrate stability on subsequent MRI scans.
  • Adults lacking capacity to give their informed consent will be excluded from participation
  • Cardiac ejection fraction < 50%
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).

Location

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    Orange California 92868 United States

Lead Scientist at UC Irvine

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT07053007
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 9 study participants
Last Updated