This is a protocol for expanded access use of nogapendekin-alfa inbakicept (NAI) inparticipants with lymphopenia induced by chemotherapy, radiation, and/or checkpointInhibitors who may benefit from its use, and who are ineligible to participate in aclinical trial using NAI. The primary objective of this protocol is to evaluate thereversal and maintenance of absolute lymphocyte count (ALC) with NAI.
It is now well established that patients undergoing standard of care chemotherapy,
radiotherapy and/or checkpoint inhibitors sustain the adverse effects of these agents
with a reduction in lymphocyte count (lymphopenia), and a significant clinical effect of
reduced overall survival across all tumor types. Severe lymphopenia is defined as
absolute lymphocyte count (ALC) < 1,000 lymphocytes per microliter as determined by the
complete blood count (CBC) differential analysis No current therapy exists for the
regeneration and proliferation of the most important immune cells in the blood
compartment responsible for cytotoxicity of tumor cells, the lymphocytes. Expanded access
of NAI for the treatment of lymphopenia addresses an unmet medical need, since no therapy
is currently approved to reverse a low lymphocyte count and maintain lymphocytes within
the normal range. By offering patients the ability to treat lymphopenia, the potential
exists of increasing overall survival.
Drug: nogapendekin-alfa inbakicept
1.2mg nogapendekin-alfa inbakicept (NAI) administered by subcutaneous injection once
every 3 weeks (on days 1 of each 3-week cycle in combination with the standard of care
schedule of chemotherapy and/or radiation and/or checkpoint inhibitor)
0.5 mg NAI for patients who are known HIV+
Other Name: NAI,N-803
Inclusion Criteria:
1. Diagnosis of solid or hematologic malignancy requiring standard-of-care treatment
with:
- Chemotherapy and/or
- Radiation therapy and/or
- Immune checkpoint inhibitor therapy
2. Lymphocyte status meeting ONE of these conditions:
- Baseline absolute lymphocyte count (ALC) <1,000 cells/μL prior to treatment
initiation
- Anticipated treatment-induced lymphopenia (ALC reduction ≥20% from baseline
based on prior therapy response)
- Persistent lymphopenia (ALC <500 cells/μL for ≥3 months during treatment)
Exclusion Criteria:
1. Active uncontrolled autoimmune disease requiring immunosuppression
2. Concurrent solid organ transplantation
Chan Soon - Shiong Institute for Medicine
El Segundo, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Paula Bradshaw, MSN, MBA, RN
213.266.5605
Paula.bradshaw@immunitybio.com
Not Provided