Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, alone or in combination with other agents, in Participants with Advanced Tumors (study 209012)

Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, alone or in combination with other agents, in Participants with Advanced Tumors (study 209012) - 209012

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52650

Enrollment

Registered

2020-09-25

Start date

2021-12-01

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non small cell lung cancer (NSCLC)

Interventions

Treatment with NY-ESO-1 and LAGE-1a specific T cells, alone or in combination with other agents. Substudy 1: GSK3901961 and substudy 2: GSK3845097.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: SUBSTUDY 1: SCREENING: • Male or female, age 18 years and above. • Measurable disease (RESIST v1.1). • Tumor sample plus report is available for NY-ESO-1 analysis. See protocol section 6.1.1 item 3. Synovial sarcoma and myxoid/round cell liposarcoma: • Diagnosis of synovial sarcoma or myxoid/round cell liposarcoma confirmed by local histology and with evidence of disease-specific translocation. • Advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma. See protocol section 6.1.1 for details. NSCLC: • Histologically or cytologically confirmed Stage IV NSCLC. LEUKAPHERESIS: • HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive and NY-ESO-1 positive. See protocol section 6.1.2 item 8-9. • Measurable disease (RECIST v1.1). • For sarcoma: Has completed at least one standard of care treatment including anthracycline containing regimen OR is intolerant to the therapy. See protocol section 6.1.2, item 12. • For NSCLC: Has been previously treated with or is intolerant to PD-1/PD-L1 checkpoint blockade therapy and a platinum-based chemotherapy, or is intolerant to it. See protocol section 6.1.2, item 13 and 14. • Left ventricular ejection fraction >=45%. See protocol section 6.1.2 item 15. • ECOG performance status 0-1. • Adequate organ function (see protocol Table 9). • Contraception guidelines for males and females should be followed, see chapter 6.1.2 item 19 of the protocol for details. • Negative pregnancy test for female participants able to become pregnant. TREATMENT: • Documented radiographic evidence of disease progression from prior line of therapy. • A biopsy of non-target tumor tissue obtained within 28 days prior to initiating the chemotherapy is mandatory. See protocol section 6.1.3 item 23 for details. For a detailed list of Iclusion Critera, please refer to the protocol for substudy 1 (page 54-59). SUBSTUDY 2 SCREENING: • Male or female, age 18 years and above. • Tumor sample plus report is available for NY-ESO-1 analysis. See protocol section 6.1.1 item 3. • Diagnosis of synovial sarcoma or myxoid/round cell liposarcoma confirmed by local histology. and with evidence of disease-specific translocation. • Advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma. See protocol section 6.1.1 for details. LEUKAPHERESIS: • HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive and NY-ESO-1 positive. See protocol section 6.1.2 item 7. • Measurable disease (RECIST v1.1). • Evidence of radiographic or clinical disease progression. • Has completed at least one standard of care treatment including anthracycline containing regimen OR is intolerant to the therapy. See protocol section 6.1.2, item 12. • Left ventricular ejection fraction >=45%. See protocol section 6.1.2 item 15. • ECOG performance status 0-1. • Adequate organ function (see protocol Table 10). • Contraception guidelines for males and females should be followed, see chapter 6.1.2 item 18 of the protocol for details. • Negative pregnancy test for female participants able to become pregnant. TREATMENT: • Documented radiographic evidence of disease progression from prior line of therapy. • A biopsy of non-target tumor tissue obtained within 28 days prior to initiating the chemoth

Exclusion criteria

Exclusion criteria: SUBSTUDY 1: SCREENING: • CNS metastases. See protocol section 6.2.2 item 6 for exceptions. • Clinically significant systemic illness, see protocol section 6.2.1, item 2 for details. • Previous treatment with genetically engineered NY-ESO-1-specific T cells NY-ESO-1 vaccine or NY-ESO-1 targeting antibody. See protocol section 6.2.1 item 3. • Prior gene therapy using an integrating vector. See protocol section 6.2.1 item 4. • Prior allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant. LEUKAPHERESIS: • CNS metastases. See protocol section 6.2.2 item 6. • History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments. • Uncontrolled intercurrent illness. See protocol chapter 6.2.2, item 9 for details. • Insufficient pulmonary function with mechanical parameters 480 msec. See protocol chapter 6.2.2, item 12 for details. • Active infections. See protocol chapter 6.2.2, item 14 for details. • NSCLC: Radiotherapy that involves the lung or bone marrow exposure or heart exposure. See protocol chapter 6.2.2, item 18 for criteria and other details. TREATMENT: • Cytotoxic therapy within the last 3 weeks prior to chemotherapy. • Systemic corticosteroids or any other immunosuppressive therapy within the last 2 weeks prior to chemotherapy. See protocol chapter 6.2.3, item 23 for details. • >=50 Gy to a significant volume of the pelvis, long bones or spine. See protocol section 6.2.3 item 20. • Radiotherapy to the target lesions within the last 3 months. See protocol chapter 6.2.3, item 24 for details. • Anti-cancer vaccine within the last 2 months prior to chemotherapy in the absence of tumor response. See protocol chapter 6.2.3, item 23 for details. • Live vaccine within the last 4 weeks prior to chemotherapy. • Immune therapy within the last 4 weeks prior to chemotherapy. See protocol chapter 6.2.3, item 25 for details. • Washout periods for prior therapy see protocol chapter 6.2.3, Table 10. For a detailed list of Exclusion Criteria please refer to the Substudy 1 protocol (Page 60-65). SUBSTUDY 2: SCREENING: • Any other prior malignancy that is not in complete remission. See protocol section 6.2.1 item 1 for exceptions. • Clinically significant systemic illness, see protocol section 6.2.1, item 2 for details. • Previous treatment with genetically engineered NY-ESO-1-specific T cells NY-ESO-1 vaccine or NY-ESO-1 targeting antibody. See protocol section 6.2.1 item 3. • Prior gene therapy using an integrating vector. See protocol section 6.2.1 item 4. • Prior allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant. LEUKAPHERESIS: • CNS metastases. • History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments. • Uncontrolled intercurrent illness. See protocol chapter 6.2.2, item 9 for details. • Insufficient pulmonary function with mechanical para

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities, (serious) adverse events (of special interest).	—

Secondary

Measure	Time frame
Overall Response Rate (ORR), Duration of Response (DoR). T cell expansion and persistence (peak expansion, Cmax, Tmax, AUC(0-t). Infiltration and phenotype of transduced T cells in the tumor by RNA, DNA and/or protein levels.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)