Status:
AVAILABLE
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
Lead Sponsor:
ImmunityBio, Inc.
Conditions:
Lymphopenia
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Active uncontrolled autoimmune disease requiring immunosuppression
- Participants with liquid tumors
- Concurrent solid organ transplantation
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06956547
Last Update
October 14 2025
Active Locations (1)
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1
Chan Soon - Shiong Institute for Medicine
El Segundo, California, United States, 90245