Engineered immune cells take aim at deadly lung cancer
NCT ID NCT07509034
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 58 times
Summary
This early-phase trial tests a new therapy for people with advanced small cell lung cancer or similar neuroendocrine cancers that have not responded to prior treatment. The approach involves collecting a patient's own immune cells, modifying them in a lab to recognize a protein called B7-H3 found on cancer cells, and infusing them back into the body. The study will enroll 40 participants to evaluate safety and determine the best dose, with follow-up lasting up to 15 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- B7-H3 CAR T cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced small cell lung cancer or similar cancers that have stopped responding to standard therapy.
- What could go wrong
- This is an early phase 1 trial with only 40 participants, so it is primarily testing safety. The treatment may not shrink tumors, and there are risks from chemotherapy and potential side effects from the modified cells.
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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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
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 to 120 years
- 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: * Age \>=18 years old. * Histologically confirmed small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancers (EP-NEC) that has recurred following or is refractory to first-line therapy. Note: small cell cancers of non-lung primary sites are also eligible. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2. * Pulse oximetry \>= 90% on room air. * Aspartate Transferase (AST) \< 3 X institutional upper limit of normal (ULN). Note: in case of liver metastases \<= 5 X ULN is acceptable. * Alanine Aminotransferase (ALT) \< 3 X institutional ULN. Note: in case of liver metastases \<= 5 X ULN is acceptable. * Total bilirubin \<=2 X institutional ULN. * Creatinine \<=1.5 X institutional ULN OR creatinine clearance (CrCl) \>= 50 mL/min/1.73m\^2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula or calculated eGFR provided by a laboratory). * Absolute Neutrophil Count (ANC) \>= 750/mcL. * Platelet count \>= 75,000/mcL. * An absolute lymphocyte count (ALC) \>=300/mcL and CD3+ cell count \>=150/mcL. * Normal cardiac ejection fraction as defined by \>= 45% by echocardiogram (ECHO) at screening. * At least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated. * Recovered from acute toxic effects of all prior cancer therapy to Grade \<2 per Common Terminology Criteria for Adverse Events (CTCAE) v.6.0 at least one week before apheresis excluding the parameters for ANC and ALC mentioned above. * The following criteria must be met prior to apheresis: * Chemotherapy and biologic/targeted agents: * \>=14 days since the last dose of standard myelosuppressive chemotherapy. * \>= 7 days since the completion of biologic agent, targeted agent, or tyrosine kinase inhibitor therapy. * \>= 3 weeks or 5 half-lives (whichever is shorter) since prior therapy with a monoclonal antibody. * Radiotherapy: * \>= 1 week since the last radiotherapy session. * No washout period required for palliative radiation to non-target lesions. * \>= 3 weeks since hepatic radiation, chemoembolization, and/or radiofrequency ablation. * Steroids and immunosuppressive therapy: * Corticosteroids: \>= 2 weeks since the therapeutic doses (\> 0.5 mg/kg/day prednisone or equivalent). Note: Inhaled or topical steroids are not exclusionary. * Physiologic replacement doses (up to 5 mg/day prednisone equivalent) are allowed and can be adjusted based on participant's BMI if warranted. * \>= 2 weeks since the other immunosuppressive medication (e.g., calcineurin inhibitors, methotrexate, rapamycin, thalidomide, etc.). * Anti-PD-1 and any investigational therapies: * \>= 2 weeks since Anti-PD-1 monoclonal antibody therapy. * \>= 2 weeks or 5 half-lives of the investigational product (whichever is shorter) since any investigational treatment or clinical trial participation. * Other criteria: * 72 hours since small molecule tyrosine kinase inhibitors (e.g., EGFR inhibitors), PARP inhibitors, or KRAS G12C inhibitors. * Individuals of childbearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \[IUD\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy. Note: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. * Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 7 months after the last dose of study drugs. We also will recommend individuals able to father a child with partners of childbearing potential ask partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period. * Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s). * Ability of the participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * History of anaphylactic reactions attributed to anti-B7-H3 antibodies or compounds of similar chemical or biologic composition to autologous B7-H3 CAR T cells, cyclophosphamide, fludarabine, or other agents used in this study. * Infection exposure with the human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) as defined below: * Positive serology for HIV. * Active HBV infection as demonstrated by test for hepatitis B surface antigen (HBsAg). * Positive serology for HCV. * Prior gene therapy using an integrating vector (except for autologous B7-H3 CAR T cells retreatment). * History of any previous allogeneic hematopoietic stem cell transplant. * Presence of fungal, bacterial, viral, or other infection is permitted if responding to active treatment. * Central Nervous System (CNS) disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that may impair the ability to evaluate neurotoxicity. * Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in IOCBP at screening. * Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history, physical exam, electrocardiogram (ECG) or situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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