This is a protocol for expanded access use of nogapendekin-alfa inbakicept (NAI) inparticipants with lymphopenia induced by chemotherapy, immunotherapy, and/or radiationtherapy who may benefit from its use, and who are ineligible to participate in a clinicaltrial using NAI. The primary objective of this protocol is to evaluate the reversal andmaintenance of absolute lymphocyte count (ALC) with NAI.
It is now well established that patients undergoing standard of care chemotherapy,
immunotherapy, and/or radiation therapy 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
1.0mg 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
Other Name: NAI,N-803
Inclusion Criteria:
1. Age ≥ 18 years old.
2. Adult patients with solid tumors who progressed on standard-of-care treatment
chemotherapy and/or immunotherapy and/or radiation therapy requiring second line or
greater standard-of-care treatment with:
- Chemotherapy and/or
- Radiation therapy and/or
- Immune checkpoint inhibitor therapy and/or any therapy investigator deems
appropriate at that institution
3. Lymphocyte status meeting ONE of these conditions:
- Baseline absolute lymphocyte count (ALC) <1,500 cells/μL (mild lymphopenia)
prior to treatment initiation in first line therapy or ALC <1000 cells/μL
(severe lymphopenia) during and or following progression after first line
therapy
- Anticipated treatment-induced lymphopenia (ALC reduction ≥20% from baseline
based on reduction during first line therapy)
- Persistent lymphopenia (ALC <1000 cells/μL for >2 months during first line
therapy treatment)
Exclusion Criteria:
1. Active uncontrolled autoimmune disease requiring immunosuppression
2. Participants with liquid tumors
3. 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