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Experimental drug offers hope for cancer patients with depleted immune cells

NCT ID NCT06956547

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This expanded access program provides nogapendekin-alfa inbakicept (NAI) to adults with solid tumors who have low lymphocyte counts caused by prior cancer treatments like chemotherapy, immunotherapy, or radiation. The goal is to reverse and maintain healthy lymphocyte levels. It is for patients who cannot join a clinical trial and will receive NAI injections every 2-3 weeks alongside their standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nogapendekin-alfa inbakicept (NAI)
What this could lead to
If it works, this could help restore immune cell levels in cancer patients whose lymphocyte counts dropped due to chemotherapy, immunotherapy, or radiation.
What could go wrong
This is an expanded access program, not a formal trial, so results are not systematically collected. It is only for patients who cannot join a clinical trial, and benefits are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years old. 2. 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 3. 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 Criteria: 1. Active uncontrolled autoimmune disease requiring immunosuppression 2. Participants with liquid tumors 3. Concurrent solid organ transplantation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chan Soon - Shiong Institute for Medicine

    AVAILABLE

    El Segundo, California, 90245, United States

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