Expanded Access Use of Nogapendekin-alfa Inbakicept for the Treatment of Lymphopenia Induced by Chemotherapy, Radiation, and Checkpoint Inhibitors

ImmunityBio

Status

Conditions: Lymphopenia

Treatments: Drug: nogapendekin-alfa inbakicept

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06956547

ResQ117EX-ALC

Details and patient eligibility

About

This is a protocol for expanded access use of nogapendekin-alfa inbakicept (NAI) in participants with lymphopenia induced by chemotherapy, radiation, and/or checkpoint Inhibitors 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.

Full description

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.

Sex: All

Volunteers: No Healthy Volunteers

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