TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy
Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Personalized, Immunotherapy, Solid Tumor, Personal, Cell Therapy, Carcinoma, Melanoma, Lung, Bladder, Cancer, Kidney, Anal, Squamous, TiTAN, ATLAS, PLANET, TiTAN-1, Autologous, Neoantigen
Eligibility Criteria
Inclusion Criteria:
- Consents to study procedures
- Diagnosis of one of the following solid tumors: cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), renal cell carcinoma (RCC), small cell lung cancer (SCLC), cutaneous squamous cell carcinoma (CSCC), anal squamous cell carcinoma (ASCC), merkel cell carcinoma (MCC).
- Received, been intolerant of, or been ineligible to receive standard of care treatment regimen.
- Measurable disease per RECIST criteria
- Life expectancy > 6 months and ECOG status 0 or 1
- Capacity to tolerate lymphodepletion (SHD group only) and IL-2 therapy
- Tumor tissue available
- Willing to use contraceptives for 90 days after receiving GEN-011, and not currently pregnant.
- Adequate blood, liver, kidney, and lung function
- Sufficient stimulatory neoantigens identified in ATLAS
Exclusion Criteria:
- Receiving immunosuppressive medications
- Serious ongoing viral, bacterial, or fungal infection
- History of cardiac arrhythmias or significant heart block
- History of leptomeningeal carcinomatosis
- Active autoimmune disease
- Portal vein thrombosis
- Malignant disease other than those treated in this study
- Receiving other investigational anti-cancer therapy
- Prior stem cell or solid organ transplant
- Primary immune deficiency disease
- Significant ongoing toxicities from prior therapies
- A history of allergic reaction to sulfur derivatives
Sites / Locations
- Banner MD Anderson Cancer Center
- Moffitt Cancer Center
- University of Chicago Medical Center
- Dana Farber Cancer Institute
- Columbia University Medical Center
- Memorial Sloan Kettering Cancer Center
- Sarah Cannon Research Institute
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Multiple Low Dose (MLD)
Single High Dose (SHD)
GEN-011 is administered by IV infusion at 4-week intervals, up to 5 doses maximum. Each dose is followed by IL-2 administration. MLD patients will not undergo lymphodepletion.
GEN-011 is administered as a single IV infusion at the maximum available cell yield, after the patient completes a fludarabine/cyclophosphamide lymphodepletion regimen. The single GEN-011 dose is followed by IL-2 administration.