Cord blood cells engineered to fight lung cancer enter human testing
NCT ID NCT05334329
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This early-phase trial tests a new treatment for people with advanced non-small cell lung cancer that has stopped responding to standard immunotherapy. The treatment uses immune cells from umbilical cord blood that are genetically modified to better recognize and attack cancer cells. Some participants also receive an additional immunotherapy drug called atezolizumab. The main goal is to check safety and find the best dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord blood natural killer cells (COH06) with or without atezolizumab
- What this could lead to
- If this works, it could point toward a new treatment option for advanced lung cancer patients whose cancer no longer responds to standard immunotherapy.
- What could go wrong
- This is a very early, small Phase 1 trial with only 6 participants, focused mainly on safety and dosing. The approach may not shrink tumors or work for everyone, and there are risks of side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Jul 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) 0 or 1 * Lung non-small cell carcinoma (NSCLC) patients with advanced, metastatic, or recurrent disease, previously treated with a PD-1 or PD-L1 immune checkpoint inhibitor, either as single agent or in combination with chemotherapy or other immunotherapy or experimental agents * Radiographically demonstrable tumor progression treatment on or after therapy with a PD-1/PD-L1 immune checkpoint inhibitor * 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 Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 * Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Hemoglobin (Hgb) \>= 8 g/dl * Platelets \>= 100,000/mm\^3 * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) =\< 1.5 x ULN * Alanine aminotransferase (ALT) =\< 1.5 x ULN * Alkaline phosphatase (AP) =\< 1.5 x ULN * Creatinine clearance of \>= 60 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 human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) * If positive, hepatitis C ribonucleic acid (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) Exclusion Criteria: * 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 magnetic resonance imaging (MRI) scans * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868, United States
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