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Cord blood cells engineered to fight lung cancer enter human testing

NCT ID NCT05334329

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Chao Family Comprehensive Cancer Center University of California, Irvine

    Orange, California, 92868, United States

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