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CAR T-cell Therapy

Engineered T Cell Therapy for Cancer

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Additional criteria for participants with non-small cell lung cancer (NSCLC):
Participant has advanced (metastatic or unresectable) SS or MRCLS confirmed by local histopathology with evidence of disease-specific translocation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until disease progression (up to 4 years)
Awards & highlights

Study Summary

This trial will test if a new cancer treatment is safe and effective.

Who is the study for?
This trial is for adults with advanced solid tumors positive for NY-ESO-1 and/or LAGE-1a. Participants must have a performance status of 0-1, adequate organ function, measurable disease, and have tried standard treatments or be ineligible/intolerant to them. Specific additional criteria apply to those with non-small cell lung cancer (NSCLC) including age, weight, and genetic markers.Check my eligibility
What is being tested?
The trial tests the safety and dose of new engineered T-cell therapies GSK3901961, GSK3845097, GSK4427296 in humans with advanced tumors. It includes preparatory chemotherapy with Cyclophosphamide and Fludarabine before T-cell therapy administration.See study design
What are the potential side effects?
Potential side effects may include immune system reactions due to engineered T-cells targeting the tumor cells which can affect normal tissues as well. Chemotherapy might cause nausea, fatigue, hair loss, increased infection risk and blood cell count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have non-small cell lung cancer.
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My cancer is advanced, cannot be surgically removed, and has a specific genetic feature.
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I am 18 or older and weigh at least 40 kg.
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My tumor is positive for NY-ESO-1 or LAGE-1a.
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I've had standard cancer treatment, including anthracycline or ifosfamide, unless I couldn't tolerate them.
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I have tried or cannot tolerate specific cancer treatments as per guidelines.
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My lung cancer is at stage IV, confirmed by tests.
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I have the HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 gene.
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I am fully active or can carry out light work.
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My organs are working well and my blood cell counts are healthy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression (up to 4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and until disease progression (up to 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Substudy 1, 2 and 3: Frequency of dose limiting toxicities (DLTs)
Substudy 1, 2 and 3:Frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) according to severity
Secondary outcome measures
Substudy 1, 2 and 3 : Time to Cmax (Tmax)
Substudy 1, 2 and 3: Area under the concentration/persistence time curve from zero to time t (AUC[0-t])
Substudy 1, 2 and 3: Duration of response (DOR)
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Substudy 3: GSK4427296 in previously treated advanced SS or MRCLSExperimental Treatment3 Interventions
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK4427296, as IV infusion after completing lymphodepleting chemotherapy.
Group II: Substudy 2: GSK3845097 in previously treated advanced SS or MRCLSExperimental Treatment3 Interventions
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3845097, as IV infusion after completing lymphodepleting chemotherapy.
Group III: Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLSExperimental Treatment3 Interventions
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as IV infusion after completing lymphodepleting chemotherapy.
Group IV: Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLCExperimental Treatment3 Interventions
Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive GSK3901961, as intravenous (IV) infusion after completing lymphodepleting chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,742 Previous Clinical Trials
8,066,350 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,593 Previous Clinical Trials
6,143,342 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors

Media Library

GSK3845097 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04526509 — Phase 1
Tumors Research Study Groups: Substudy 3: GSK4427296 in previously treated advanced SS or MRCLS, Substudy 1: Cohort 1 - GSK3901961 in previously treated metastatic NSCLC, Substudy 1: Cohort 2 - GSK3901961 in previously treated advanced SS or MRCLS, Substudy 2: GSK3845097 in previously treated advanced SS or MRCLS
Tumors Clinical Trial 2023: GSK3845097 Highlights & Side Effects. Trial Name: NCT04526509 — Phase 1
GSK3845097 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04526509 — Phase 1

Frequently Asked Questions

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

What risks does GSK3901961 pose to human health?

"Based on the level of safety and efficacy data available, GSK3901961 was given a score of 1. This is due to it being currently in Phase 1 trials."

Answered by AI

What goals is this trial hoping to accomplish?

"The primary objective of this trial, measured over a four year period, is to evaluate the frequency of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI). Secondary objectives encompass duration of response in those who demonstrate complete or partial remission, phenotype analysis on transduced T cells, and time taken for maximum concentration."

Answered by AI

How many people are being accepted into this scientific experiment?

"Affirmative. According to evidence hosted on clinicaltrials.gov, this experiment is actively searching for participants and was first posted in December 2020 with an update made in August 2022. The study requires 67 volunteers evenly distributed across 12 different sites."

Answered by AI

Are there any recruitment opportunities available for this trial currently?

"Affirmative. The information hosted on clinicaltrials.gov attests that this medical trial is now recruiting participants and was first published in December 2020. As of August 2022, 67 patients must be enrolled across 12 different sites to take part in the study."

Answered by AI

Would you be able to provide details on prior investigations involving GSK3901961?

"GSK3901961 was initially trialed in 1997 at City of Hope Comprehensive Cancer Center. Now, there are a total of 1275 completed studies and 889 ongoing trials--particularly prominent in Montreal, Quebec."

Answered by AI

For what medical issues is GSK3901961 usually prescribed?

"GSK3901961 is chiefly deployed to control the progression of multiple sclerosis, but it has also demonstrated efficacy in treating mixed-cell type lymphoma, leukemia, myelocytic acute retinoblastoma."

Answered by AI

How many healthcare facilities have been selected to conduct this experiment?

"The current medical trial is accepting participants from 12 different sites, including Montreal, Saint Louis and Lexington. To reduce the need for travel during this study, it is suggested that you select a clinic in close proximity to your location."

Answered by AI
~4 spots leftby Dec 2025