Phase
Condition
Small Cell Lung Cancer
Treatment
LB2102
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be at least 18 years of age and willing and able to provide a written informedconsent
Have histologically/cytologically confirmed unresectable small cell lung carcinoma (SCLC), large cell neuroendocrine lung carcinoma (LCNEC), combined SCLC, or combinedLCNEC as per WHO 2021 criteria
Subjects who have at least one prior line of standard treatment, and have progressedafter or have had an insufficient response, and for whom standard treatment isintolerable, unlikely to confer significant clinical benefit, is no longereffective, or the subject declines further standard treatment
Have available formalin-fixed, paraffin-embedded tumor specimen in a tissue block orunstained serial slides accompanied by an associated pathology report prior toenrollment. Archival or fresh biopsy tissue is required
Presence of ≥ 1 radiologically measurable lesion per Response Evaluation Criteria InSolid Tumors (RECIST) Version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 4 months
Have adequate organ function
Women of childbearing potential must have a negative pregnancy test at screeningusing a highly sensitive serum pregnancy test (β-human chorionic gonadotropin [β-hCG])
All subjects must agree to practice a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) from the time ofsigning the informed consent form (ICF) to 1 year after receiving a LB2102 infusion
Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively,until at least 1 year after receiving a LB2102 infusion
Exclusion
Exclusion Criteria:
Prior treatment with cellular immunotherapy (e.g., CAR-T) or gene therapy product
Prior treatment with DLL3-targeted therapy
Prior history of checkpoint inhibitor associated pneumonitis
Clinically significant ascites, pleural or peritoneal effusions
Known status of acquired or inherited immunodeficiency without the ability ofmedical control or normalization.
Known leptomeningeal metastases
Active or symptomatic brain metastasis. Subjects with treated brain metastasis areallowed provided definitive therapy was completed at least 2 weeks prior toenrollment with at least documented stable disease and the subject is offsupraphysiologic doses of steroid for at least 7 days. Additional requirements aremet per protocol.
Active autoimmune disease receiving immunomodulatory treatments (e.g., cyclosporineor high dose systemic steroids) prior to screening as follows:
Within 2 weeks or 5 half-lives, whichever is longer
Those with steroid replacement at physiologic doses and inhaled steroidsrecently or currently are not excluded.
Impaired cardiac function or clinically significant cardiac disease not controlledby medications including:
Unstable angina or myocardial infraction within 6 months prior to apheresis.
History of cardiomyopathy with left ventricular ejection fraction (LVEF)<45% asassessed by ECHO and MUGA scan.
Previous or concurrent malignancy, excluding certain exceptions.
Serious and /or uncontrolled medical condition that, in the Investigator's judgment,would cause unacceptable safety risk, interfere with study procedures or results, orcompromise compliance with the protocol, such as:
Active, uncontrolled, viral bacterial or systemic fungal infections.
Requirement if supplemental oxygen to maintain oxygen saturation.
Clinical evidence of dementia or altered mental status.
Medically uncontrolled condition or insufficient recovery from an acute event within 6 months of screening.
Subjects with known active infection with HIV, hepatitis B, and/or hepatitis C virus (HBV/HCV) are not eligible unless additional protocol requirements are met.
subjects with HIV must be controlled on effective antiretroviral therapy for atleast four weeks and have HIV viral load of less than 400 copies/mL prior toenrollment.
subjects with active HBV must be on suppressive antiviral therapy prior toenrollment in the study.
For subject with history of HBV and with serologic evidence of a resolved priorinfection, the risk of HBV reactivation must be considered, and the need foranti-HBV prophylaxis must be carefully assessed prior to enrollment in the study.
Subjects with untreated HCV infection may be eligible if the HCV is stable, thesubject is not at risk for hepatic decompensation and the investigational cancertreatment is not expected to exacerbate the HCV infection.
Contraindications or life-threatening allergies, hypersensitivity, or intolerance toLB2102 excipients, such as dimethyl sulfoxide; or to fludarabine, cyclophosphamide,or tocilizumab
Ongoing toxicity of organ functions from previous anticancer therapy that has notresolved to Grade 1 or less, except for alopecia
Major surgery within 4 weeks prior to apheresis, or planned within 4 weeks afterLB2102 administration
Pregnant or breast-feeding
Plans to become pregnant or breastfeed, or father a child within 1 year afterreceiving a LB2102 infusion
Previous history of allogeneic hematopoietic (HSCT), organ transplant.
Study Design
Study Description
Connect with a study center
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
University of Kentucky - Markey Cancer Center
Lexington, Kentucky 40536
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10017
United StatesSite Not Available

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