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
Available (expanded access)
Conditions studied: Lymphopenia
In brief
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.
Key facts
- Study ID
- NCT06956547
- Run by
- ImmunityBio, Inc.
- Last updated by the study team
- 2025-10-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years old.
- 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
- 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)
You may not qualify if…
- Active uncontrolled autoimmune disease requiring immunosuppression
- Participants with liquid tumors
- Concurrent solid organ transplantation
Where it is running
- Chan Soon - Shiong Institute for Medicine — El Segundo, California, United States
Full record on ClinicalTrials.gov
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