ImmunityBio Pipeline

Solid Tumors
Disease
Triangle Offense
Trial Sites/Collaborators
Pre-Ind
Phase 1
Phase 2
Phase 3
Phase
Bladder Cancer:
BCG Unresponsive NMIBC Carcinoma In-Situ (CIS)
AnktivaDetails
32 study locations (See clinicaltrials.gov for details)
Phase 3
x

Bladder BCG Unresponsive NMIBC Carcinoma In-Situ (CIS)

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

NCT03022825

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Bladder Cancer:
BCG Unresponsive NMIBC Papillary
AnktivaDetails
24 study locations (see Clinicaltrials.gov for details)
Phase 2
x

A Study of Intravesical BCG in Combination With ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer

NCT02138734

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Lung Cancer:
2L or Greater Lung Cancer, Checkpoint Relapsed Basket Trial
Anktiva + PD-L1 t-haNKDetails
35 study locations (See clinicaltrials.gov for details)
Phase 2b
x

2L or Greater Lung Cancer, Checkpoint Relapsed Basket Trial

QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors

NCT03228667

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Lung Cancer:
1L Non-Small Cell Lung Cancer Checkpoint + Concurrent Chemo
AnktivaDetails
25 study locations (See clinicaltrials.gov for details)
Phase 3
x

1L Non-Small Cell Lung Cancer Checkpoint + Concurrent Chemo

QUILT 2.023: A Study of N-803 in Combination with Current Standard of Care vs Standard of Care as First-Line Treatment for Patients With Stage 3 or 4 NSCLC.

NCT03520686

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Pancreatic Cancer:
1L/2L/3L Metastatic Pancreatic Cancer
Anktiva + Aldox + PD-L1 t-haNKDetails
Hoag Memorial Presbyterian Hospital (Newport Beach, CA); Avera Cancer Institute (Sioux Falls, SD)
Phase 2
x

1L/2L/3L Metastatic Pancreatic Cancer

QUILT 88: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for First- and Second-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

NCT04390399

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Breast Cancer:
3L or Greater Triple Negative Breast Cancer
Anktiva + PD-L1 t-haNKDetails
Enrollment expected to begin in Q3 2021
Phase 1
x

3L or Greater Triple Negative Breast Cancer

QUILT 3.058: A Study of Sacituzumab (Trodelvy) With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies

This is a phase 1b/2 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-hziy (Trodelvy) in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects with Triple Negative Breast Cancer (TNBC) after at least 2 prior treatments for metastatic disease.

NCT04927884

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Skin Cancer:
Recurrent Merkel Cell Carcinoma
Aktiva + haNKDetails
University of California San Francisco; University of Miami, Sylvester Comprehensive Cancer Center (Miami); Miami Cancer Institute – Baptist Health (Miami); Washington University School of Medicine (St. Louis, MO); Cleveland Clinic Foundation (Cleveland, OH)
Phase 2
x

Recurrent Merkel Cell Carcinoma

QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients with Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy

NCT03853317

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Glioblastoma:
Phase I Recurrent Glioblastoma
HER2 t-haNKDetails
Johann Wolfgang Goethe University Hospital (Frankfurt, Germany), Johann W. Goethe University Hospital, Senckenberg Institute of Neuro-oncology (Frankfurt, Germany)
Phase 1
Advanced Solid Tumors:
Advanced Solid Tumors, M-ceNK
M-ceNKDetails
Chan Soon-Shiong Institute for Medicine (El Segundo, CA) & Hoag Memorial Hospital Presbyterian (Newport Beach, CA)
Phase 1
x

Advanced Solid Tumors, M-ceNK

QUILT 3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors

This is a two-part, open-label phase 1 study to evaluate safety and preliminary efficacy of M-CENK and N-803 for subcutaneous administration, cryopreserved in subjects with locally advanced or metastatic solid tumors.

NCT04898543

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Liquid Tumors
Lymphomas, AML, MDS:
Diffuse Large B Cell Lymphoma
Anktiva + M-ceNKDetails
Enrollment expected to begin in Q4 2021
Phase 1

x

Lymphomas, AML, MDS: Diffuse Large B Cell Lymphoma

QUILT 3.076: Study of Autologous M-CENK in Subjects with Locally Advanced or Metastatic Solid Tumors

This two-part, open-label phase 1 study will evaluate safety and preliminary efficacy of M-CENK and N-803 for subcutaneous administration, cryopreserved in subjects with locally advanced or metastatic solid tumors.

NCT04898543

Here is relevant research:
FDA Authorizes ImmunityBio to Conduct a Trial of its First-in-Human, Cryopreserved, Memory Cytokine-Enriched NK Cell (m-ceNK) Platform in Solid Tumors

Cytokine-induced memory-like natural killer cells exhibit enhanced responses against myeloid leukemia


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Infectious Diseases
HIV:
HIV Thai Red Cross: Reducing HIV Persistence by IL-15
AnktivaDetails
Thai Red Cross AIDS Research Centre
Henry M. Jackson Foundation for the Advancement of Military Medicine
Walter Reed Army Institute of Research (WRAIR)
Phase 2
COVID-19:
COVID-19 Vaccine: hAd5 S+N USA (SC, SC)
hAd5 S+NDetails
Hoag Memorial Hospital Presbyterian (Newport Beach, Calif.)
Phase 1
x

COVID-19: COVID-19 Vaccine: hAd5 S+N USA (SC, SC)

This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.

NCT04591717

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COVID-19:
COVID-19 Vaccine: hAd5 S+N USA (SC, Oral)
hAd5 S+NDetails
Hoag Memorial Hospital Presbyterian (Newport Beach, Calif.)
Phase 1
x

COVID-19: COVID-19 Vaccine: hAd5 S+N USA (SC, Oral)

This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity the combination of hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) and to select an optimal combination dose for future studies.

NCT04732468

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COVID-19:
COVID-19 Vaccine: hAd5 S+N South Africa (SC, SC)
hAd5 S+NDetails
Khayelitsha Clinical Research Center, Khayelitsha, South Africa
Phase 1
x

COVID-19 Vaccine: hAd5 S+N South Africa (SC, SC)

COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults

This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.

NCT04710303

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We are actively recruiting participants for these trials. For a list of completed trials or trials in development, please visit the IR section of our website.

Anktiva™ (N-803) is an IL-15RαFc Superagonist, a proprietary therapeutic cytokine designed to induce expansion of native NK and CD8+ T-cells without concurrent stimulation of T-regulatory cells; Aldoxorubicin (Aldox) is a proprietary albumin-bound doxorubicin complex that is designed to preferentially accumulate in a tumor’s low pH environment. Both agents are in late-stage clinical development by ImmunityBio, which has exclusive, worldwide rights to the agents. Avelumab is an FDA approved checkpoint inhibitor marketed by Pfizer.
QUILT stands for QUantum Integrative Lifelong Trial.

How Can ImmunityBio Help You?

Solutions for Patients

Many therapies for treating cancer and infectious diseases 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

Natural killer cell-based immunotherapies are key to future cancer treatments. Our investigational NK-92®-engineered cells have demonstrated wide therapeutic potential across multiple tumor types, and, in clinical studies, have proven to be well-tolerated, making them ideal for clinical trial investigations.

Solutions for Research Scientists

Our NK-92® cell line provides a versatile bioanalytical testing solution that helps 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.