Engineered T Cell Therapy for Cancer

Palo Alto (17 mi)

Overseen byAdaptimmune Patient Enquiries

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Adaptimmune

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial will evaluate the safety and efficacy of first time in human engineered T-cell therapies, in participants with advanced tumors.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is advanced, cannot be surgically removed, and has a specific genetic feature.

I am 18 or older and weigh at least 40 kg.

My tumor is positive for NY-ESO-1 or LAGE-1a.

My lung cancer is at stage IV, confirmed by tests.

I have the HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 gene.

I am fully active or can carry out light work.

Exclusion Criteria

I have not had major surgery in the last 4 weeks.

I have a severe autoimmune disease treated with steroids or immunosuppressants in the last year.

I have a history of or currently have a demyelinating disease.

I have had gene therapy with an integrating vector before.

I have another cancer that is not fully in remission.

I have been treated with NY-ESO-1 specific therapies before.

Treatment Details

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.

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.