Lymphopenia Clinical Trial

Lymphopenia, also known as lymphocytopenia, is a condition marked by abnormally low levels of lymphocytes – white blood cells that are essential for immune defense. It can occur as a result of cancer itself or as a side effect of cancer treatments such as chemotherapy or radiation.

Lymphopenia

When lymphocyte counts fall too low, the immune system becomes less able to detect and fight infections and abnormal cells, including cancer. This compromised state can leave patients vulnerable to complications and limit their ability to continue cancer therapy.

Lymphopenia Clinical Trials

ImmunityBio’s BioShield™ platform, featuring the novel agent ANKTIVA® (N-803/NAI), has been granted Expanded Access authorization by the U.S. Food and Drug Administration (FDA) for use in patients with refractory or relapsed solid tumors and lymphopenia.
ANKTIVA® is designed to activate and expand memory T cells and natural killer (NK) cells, enhancing the immune system’s response while avoiding depletion of immune cells. By helping restore lymphocyte levels, this therapy may offer a new pathway to immune recovery for patients whose immune systems have been weakened by cancer or its treatment.

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 (N-803/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 N-803/NAI.

Select Eligibility Criteria:

  • 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
  • You can review a list of all eligibility criteria at ClinicalTrials.gov (link below).
Dr. Patrick Soon-Shiong
Global Chief Scientific and Medical Officer, ImmunityBio
Glioblastoma is not only one of the most common tumors of brain tissue, it also is one of the most lethal cancers. By orchestrating the body’s protective NK and T cells, we believe we can potentially train the immune system to target and even destroy the tumor cells of glioblastoma and other cancers.

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Solutions for Patients

Many cancer therapies, including radiation therapy, chemotherapy, CAR-T therapy, and B-cell immunotherapy, severely weaken the immune system—the human body’s most important natural disease-fighting weapon. But ImmunityBio creates targeted, personalized immunotherapies that are designed to strengthen the immune system and enable it to outsmart your disease.

Opportunities for Trial Investigators

The broad therapeutic potential and demonstrated safety of ImmunityBio’s immune-enhancing IL-15 superagonist Anktiva (N-803), engineered NK-92® cell-based therapies, and our next-generation adenovirus-vectored anti-cancer vaccines make them appealing therapeutics for testing by trial investigators who want to make a contribution to clinical cancer research. Interested clinicians and other are encouraged to contact ImmunityBio to find out how they may support discovery of future cancer treatments.

Tools for Research Scientists

Our NK-92® easy-to-maintain and highly cytotoxic natural killer cell line provides a versatile bioanalytical testing tool that can help researchers develop functional killing assays that are more consistent and reliable than donor blood and reporter gene assays.

ImmunityBio is continuously pursuing new immunotherapies designed to attack disease by enhancing the patient’s immune system, not weakening it.

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