Phase 1
Completed N=10
Letetresgene Autoleucel Engineered T Cells in NY-ESO -1 Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Neoplasms
Source: ClinicalTrials.gov NCT02588612 ↗
Enrolled (actual)
10
Serious AEs
40.0%
Results posted
Sep 2021
Primary outcomePrimary: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) — 6; 4 Participants
Summary
This trial will evaluate safety and efficacy of letetresgene autoleucel (GSK3377794) in participants with metastatic NSCLC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 4 | — |
| PRIMARY Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline |
0; 3; 1; 5; 5; 5 | — |
| PRIMARY Number of Participants With Any Grade Increase in Clinical Chemistry Parameters |
2; 0; 2; 2; 3; 4 | — |
| PRIMARY Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings |
2; 1 | — |
| PRIMARY Change From Baseline in Oxygen Saturation |
2.0; 2.5; 2.0; 3.0; 2.0; 1.5 | — |
| SECONDARY Overall Response Rate (ORR) |
20 | — |
| SECONDARY Time to Response |
12.09 | — |
| SECONDARY Duration of Response |
6.18 | — |
| SECONDARY Disease Control Rate (DCR) |
20 | — |
| SECONDARY Progression-Free Survival (PFS) by Investigator Assessment |
1.81 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is >=18 years of age on the day of signing informed consent.
- Participant has a diagnosis of histologically or cytologically confirmed advanced non-small cell lung cancer (Stage IIIB or IV) or recurrent disease.
- Participants with known epidermal growth factor receptor (EGFR) mutations or Anaplastic lymphoma kinase receptor (ALK) or ROS1 gene rearrangements must have failed (disease progression [PD] or unacceptable toxicity) prior EGFR or ALK or ROS1 tyrosine kinase inhibitor, respectively (PD or unacceptable toxicity). There is no limit to lines of prior anti-cancer therapy.
- Participant has measurable disease according RECIST v1.1 criteria.
- Participant is HLA-A*02: 01, HLA-A*02:05 and/or HLA-A*02:06 positive.
- Participant's tumor is positive for NYESO and/or LAGE-1a expression by a designated central laboratory.
- Participant has Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Participant has an anticipated life expectancy >3 months.
- Participant has left ventricular ejection fraction >=50 percent(%).
- Participant is fit for leukapheresis and has adequate venous access for the cell collection.
- Male or Female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participant must have adequate organ function.
Exclusion Criteria
- Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per Investigator assessment).
- Washout periods for prior radiotherapy and chemotherapy and other systemic therapy must be followed.
- Experimental anti-cancer vaccine within 2 months prior to leukapheresis in the absence of response or in the opinion of the Investigator is responding to an experimental vaccine given within 6 months prior to leukapheresis.
- Any prior gene therapy using an integrating vector.
- Toxicity from previous anti-cancer therapy that has not recovered to less than or equal to ( 10% in 6 months preceding study entry.
- Corrected QT interval (QTc) >450 milliseconds (msec) or QTc >480 msec for participants with Bundle Branch Block (BBB).
- Uncontrolled intercurrent illness.
- Participants who in the opinion of the Investigator will be unlikely to fully comply with protocol requirements.
- Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or human T-cell lymphotropic virus (HTLV).
- Participant is pregnant or breastfeeding.
- Major surgery within 4 weeks prior to lymphodepleting chemotherapy.
Data sourced from ClinicalTrials.gov (NCT02588612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.