Umbilical CB-NK Expressing sIL-15 & PD-L1 +/- Atezolizumab in NSCLC Pts Refractory to PD-1/PD-L1
a study on Lung Cancer Non-Small Cell Lung Cancer Lung Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Orange, California
- Dates
- study startedstudy 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