This is a protocol for expanded access use of nogapendekin-alfa inbakicept (NAI) in participants with lymphopenia induced by chemotherapy, immunotherapy, and/or radiation therapy who may benefit from its use, and who are ineligible to participate in a clinical trial using NAI. The primary objective of this protocol is to evaluate the reversal and maintenance of absolute lymphocyte count (ALC) with NAI.
Age ≥ 18 years old.
Chemotherapy and/or
Radiation therapy and/or
Immune checkpoint inhibitor therapy and/or any therapy investigator deems appropriate at that institution
Active uncontrolled autoimmune disease requiring immunosuppression
Participants with liquid tumors
Concurrent solid organ transplantation
nogapendekin-alfa inbakicept
Drug1.0mg nogapendekin-alfa inbakicept (NAI) administered by subcutaneous injection no less than every 3 weeks and no more frequently than every 2 weeks between doses in combination with the standard of care schedule of chemotherapy, immunotherapy, and/or radiation therapy. Patients who are known HIV+ will be dosed with NAI at 0.5 mg
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