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CAR T-cell Therapy
CAR T-Cell Therapy for Small Cell Lung Cancer
Phase 1
Recruiting
Research Sponsored by Legend Biotech USA Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have histologically/cytologically confirmed unresectable small cell lung carcinoma (SCLC), large cell neuroendocrine lung carcinoma (LCNEC), combined SCLC, or combined LCNEC as per WHO 2021 criteria
Have available formalin-fixed, paraffin-embedded tumor specimen in a tissue block or unstained serial slides accompanied by an associated pathology report prior to enrollment. Archival or fresh biopsy tissue is required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, a minimum of 2 years
Awards & highlights
Study Summary
This trial tests a new cancer treatment for people with advanced lung cancer.
Who is the study for?
This trial is for adults with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer who've had prior treatment but didn't respond well, can't tolerate further standard treatments, or chose not to continue them. They must be in relatively good health (ECOG status of 0 or 1), have a life expectancy of at least 4 months, and agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing LB2102, a new type of therapy involving T-cells engineered to target DLL3 on cancer cells. It's an early-phase trial designed to find the right dose and assess how safe it is for patients with specific types of lung cancer.See study design
What are the potential side effects?
Potential side effects are not detailed here as this is a first-in-human study; however, similar therapies often cause immune reactions, fatigue, fever, and may affect normal blood counts leading to increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer cannot be removed by surgery and fits specific types.
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I can provide a tissue sample of my tumor for the study.
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I have enough non-mobilized cells available for treatment creation.
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I am fully active or can carry out light work.
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I agree not to donate eggs or sperm for 1 year after my LB2102 infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, a minimum of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, a minimum of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To characterize the safety and tolerability of LB2102 and determine recommended dose for expansion (RDE)
To further characterize the safety and tolerability of LB2102 with the RDE identified in the dose-escalation and determine the recommended Phase 2 dose (RP2D)
Secondary outcome measures
To characterize the pharmacokinetics of LB2102 in blood
To evaluate the immunogenicity of LB2102
To evaluate the preliminary efficacy of LB2102
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental LB2102Experimental Treatment1 Intervention
DLL3-Directed Chimeric Antigen Receptor T-cells (CAR T)
Find a Location
Who is running the clinical trial?
Legend Biotech USA IncLead Sponsor
2 Previous Clinical Trials
106 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or am preparing for a stem cell or organ transplant.My cancer has spread to the lining of my brain and spinal cord.I have brain metastasis but it's either treated or not causing symptoms.My lung cancer cannot be removed by surgery and fits specific types.I can provide a tissue sample of my tumor for the study.I haven't had major surgery in the last 4 weeks and don't plan to have any in the next 4 weeks.I have enough non-mobilized cells available for treatment creation.I've had treatment for my condition, but it didn't work or I couldn't tolerate it.I am receiving treatment for an autoimmune disease.I am fully active or can carry out light work.I am 18 or older and can sign a consent form.Women who could become pregnant must have a negative pregnancy test using a sensitive blood test.I have had cancer before, but it fits the exceptions.I am not allergic to LB2102, dimethyl sulfoxide, fludarabine, cyclophosphamide, or tocilizumab.I have previously been treated with DLL3-targeted therapy.I have previously received cellular immunotherapy or gene therapy.I still have side effects from cancer treatment, except for hair loss.I have had lung inflammation from previous cancer immunotherapy.I do not have an active HIV, HBV, or HCV infection, or I meet the specific requirements if I do.My heart condition is not well-managed with medication.My organs are functioning well.You are expected to live for at least 4 more months.I have fluid buildup in my abdomen or chest.I have a condition that weakens my immune system.I agree not to donate eggs or sperm for 1 year after my LB2102 infusion.You have at least one visible lesion that can be measured using specific guidelines for evaluating tumors.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental LB2102
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being accepted into the research project?
"In order to conduct the study, 41 eligible participants are needed. Legend Biotech USA Inc will be leading this trial from University of Kentucky - Markey Cancer Center in Lexington and Dana-Farber Cancer Institute in Boston."
Answered by AI
Are there opportunities for participants to join the current clinical experiment?
"Yes, the trial is still recruiting candidates. Clinicaltrials.gov identifies that it was posted on 26 July 2023 and last updated on the same date."
Answered by AI
To what degree might patients be at risk from taking Experimental LB2102?
"Our team at Power assigned Experimental LB2102 a score of 1, as this is an early stage clinical trial with scant evidence supporting its safety and effectiveness."
Answered by AI
What are the various facilities conducting this trial?
"At the moment, 4 medical centres are overseeing this trial. Lexington, Boston and New york each host one of these sites while a fourth site is located elsewhere. To reduce travel demands should you choose to participate in this study, it's advisable to seek out the closest clinic available."
Answered by AI
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