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CAR T-cell Therapy

Lete-cel for Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 10 months

Awards & highlights

Study Summary

This trial will see if a new treatment is safe and tolerable for people with non-small cell lung cancer, with or without another existing treatment.

Eligible Conditions

Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With AEs Leading to Dose Delays

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades

+2 more

Secondary outcome measures

Area Under the Plasma Concentration-time Curve to Day 28 (AUC0-28d) of Lete-cel

Disease Control Rate (DCR) Per RECIST Version 1.1 by Investigator Assessment

Duration of Response (DOR) Per RECIST Version 1.1 by Investigator Assessment

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C: lete-cel plus pembrolizumabExperimental Treatment2 Interventions

In Arm C, participants with NSCLC (with actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.

Group II: Arm B: lete-cel plus pembrolizumabExperimental Treatment2 Interventions

In Arm B, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.

Group III: Arm A: lete-cel monotherapyExperimental Treatment2 Interventions

In Arm A, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel monotherapy. Participants who subsequently progress by Week 25 will be offered pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,749 Previous Clinical Trials

8,067,402 Total Patients Enrolled

5 Trials studying Tumors

1,919 Patients Enrolled for Tumors

Merck Sharp & Dohme LLCIndustry Sponsor

3,878 Previous Clinical Trials

5,053,163 Total Patients Enrolled

11 Trials studying Tumors

2,324 Patients Enrolled for Tumors

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,904 Total Patients Enrolled

1 Trials studying Tumors

12 Patients Enrolled for Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other experiments have been conducted to study the effects of Lete-cel?

"The initial research into Lete-cel was conducted at City of Hope in 2010, and since then 251 investigations have been concluded. Currently, 961 trials are being performed across the United States with a large proportion originating out of La Jolla, California."

Answered by AI

Are there any opportunities for prospective participants to join this investigation?

"Unfortunately, this trial is no longer in the recruitment phase. It was initially posted on December 31st 2018 and last edited September 11th 2022. Fortunately there are a plethora of other clinical trials that may interest you; 4157 searching for patients with cancer and 961 looking to recruit those suffering from Lete-cel specifically."

Answered by AI

In what conditions is Lete-cel most frequently prescribed?

"Lete-cel is an effective therapeutic agent for treating malignant neoplasms, with potential applications in the management of unresectable melanoma, microsatellite instability high, and post-chemotherapy disease progression."

Answered by AI

What is the participant count for this experimental research?

"Unfortunately, registration for this clinical trial has closed; the initial post was made on December 31st 2018 and it's most recent update took place on September 11th 2022. If you are still looking to participate in a study, there are currently 4157 cancer studies and 961 Lete-cel related studies actively recruiting participants."

Answered by AI

Are any healthcare centers in North America conducting this medical experiment?

"Presently, 19 sites across the country are administering this clinical trial. Locations include La Jolla, Lexington and Iowa City, among others. Prospective patients should select their nearest site to reduce travel burdens associated with enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

2018. "Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03709706.