Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Advanced Ovarian Carcinoma
- Advanced Fallopian Tube Carcinoma
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Platinum-Resistant Fallopian Tube Carcinoma
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Advanced Malignant Solid Neoplasm
- Metastatic Primary Peritoneal Carcinoma
- Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
- Unresectable Ovarian Carcinoma
- Advanced Melanoma
- Advanced Primary Peritoneal Carcinoma
- Advanced Synovial Sarcoma
- Stage IVA Ovarian Cancer AJCC v8
- Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Platinum-Resistant Ovarian Carcinoma
- Stage IV Ovarian Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Stage IIIA Fallopian Tube Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Platinum-Resistant Primary Peritoneal Carcinoma
- Stage IIIB Fallopian Tube Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA1 Fallopian Tube Cancer AJCC v8
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Metastatic Fallopian Tube Carcinoma
- Metastatic Melanoma
- Unresectable Synovial Sarcoma
- Stage III Fallopian Tube Cancer AJCC v8
- Stage IIIA2 Fallopian Tube Cancer AJCC v8
- Metastatic Synovial Sarcoma
- Metastatic Ovarian Carcinoma
- Pathologic Stage III Cutaneous Melanoma AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage IIIC Fallopian Tube Cancer AJCC v8
- Unresectable Melanoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To evaluate the safety and feasibility of adoptive transfer of TGFbDNRII-transduced autologous tumor infiltrating lymphocytes (autologous NY-ESO-1 TCR/dnTGFbetaRII transgenic T cells). SECONDARY OBJECTIVES: I. NY-ESO-1 TCR/ dnTGFbetaRII transgenic T cell persistence by analyzin...
PRIMARY OBJECTIVE: I. To evaluate the safety and feasibility of adoptive transfer of TGFbDNRII-transduced autologous tumor infiltrating lymphocytes (autologous NY-ESO-1 TCR/dnTGFbetaRII transgenic T cells). SECONDARY OBJECTIVES: I. NY-ESO-1 TCR/ dnTGFbetaRII transgenic T cell persistence by analyzing serial peripheral blood samples for the presence of T cells with the NY-ESO-1 TCR by tetramer analysis. II. To study T cell differentiation that correlates with higher anti-tumor responses. III. To test the hypothesis that NY-ESO-1 TCR/dnTGFbetaRII will constitute in cells more efficient in inducing tumor regression. IV. Determine objective tumor responses by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1. EXPLORATORY OBJECTIVE: I. To evaluate the role of microbiota on the therapeutic efficacy of the proposed therapy. OUTLINE: This is a phase I, dose-escalation study of NY-ESO-1 TCR/TGFbDNRII-transduced TILs followed by a phase IIa study. Participants are assigned 1 to 2 cohorts. COHORT I: Patients undergo leukapheresis on day -6, and receive cyclophosphamide intravenously (IV) over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. COHORT II: Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. After completion of study treatment, patients are followed up at weeks 1-4, 6, 8, and 12, at 6 and 9 months, every 6 months for 5 years, and then yearly for 10 years.
Tracking Information
- NCT #
- NCT02650986
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Richard Koya, MD Roswell Park Cancer Institute