LymphopeniaNCT06956547
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
A study testing nogapendekin-alfa inbakicept in people with Lymphopenia, run by ImmunityBio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphopenia
- What is being tested?
- nogapendekin-alfa inbakicept
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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)
Who cannot join
- Active uncontrolled autoimmune disease requiring immunosuppression
- Participants with liquid tumors
- Concurrent solid organ transplantation
Trial locations and contacts
1 site in 1 country.
Atessa Kiani, MD contact
United States1 site
- Available
Chan Soon - Shiong Institute for Medicine
El Segundo, California, 90245
Mini Gill, Jaya.Gill@cssifm.org
Tara Seery, MD
About this study
Official title: ResQ117EX-ALC: 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
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.
Read the 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 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.
- Conditions
- Lymphopenia
- Being tested
- nogapendekin-alfa inbakicept
- Keywords
- lymphopenia, lymphopenia induced by chemotherapy, lymphopenia induced by radiation therapy, lymphopenia induced by immunotherapy, absolute lymphocyte count
- Medical subject headings
- Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nogapendekin-alfa inbakiceptDrug
Also called NAI, N-803
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphopeniaStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956547
- Sponsor's protocol ID
- ResQ117EX-ALC
- Status last verified
- Oct 2025
- First submitted
- 25 Apr 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ResQ117EX-ALC: 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
- ClinicalTrials.gov ID
- NCT06956547
- Acronym / sponsor ID
- ResQ117EX-ALC
- Conditions
- Lymphopenia
- Keywords
- lymphopenia, lymphopenia induced by chemotherapy, lymphopenia induced by radiation therapy, lymphopenia induced by immunotherapy, absolute lymphocyte count
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Lymphocyte status meeting ONE of these conditions:
Key exclusion criteria (3 listed)
- Active uncontrolled autoimmune disease requiring immunosuppression
- Participants with liquid tumors
- Concurrent solid organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nogapendekin-alfa inbakiceptAlso: NAI, N-8031.0mg 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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atessa Kiani, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nogapendekin-alfa inbakicept in people with Lymphopenia, run by ImmunityBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Nelson (213-414-3566, mark.nelson@immunitybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.