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 | Unknown

• 1 other identifier: ResQ117EX-ALC
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Lymphopenia

Keywords

lymphopenia; lymphopenia induced by chemotherapy; lymphopenia induced by radiation therapy; lymphopenia induced by immunotherapy; absolute lymphocyte count

Interventions

nogapendekin-alfa inbakicept 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

Also known as: NAI, N-803

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Chan Soon - Shiong Institute for Medicine

El Segundo, California, 90245, United States

AVAILABLE

MeSH Terms

Conditions

Lymphopenia

Interventions

ALT-803

Condition Hierarchy (Ancestors)

Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Mark Nelson

CONTACT

213-414-3566; mark.nelson@immunitybio.com

Atessa Kiani, MD

CONTACT

atessa.kiani@immunitybio.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)