Expanded Access Use of Nogapendekin-alfa Inbakicept in the Reversal and Maintenance of Absolute Lymphocyte Count (ALC) for the Treatment of Lymphopenia Induced by Chemotherapy, Immunotherapy, and/or Radiation Therapy
NCT06956547 · Status: AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2025-10-14
Summary
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.
Conditions
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
ImmunityBio, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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