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) & Papillary
Anktiva + BCGDetails
32 study locations (See clinicaltrials.gov for details)
Phase 3
x

BCG Unresponsive NMIBC Carcinoma In-Situ (CIS) & Papillary

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 Naïve NMIBC CIS & Papillary
Anktiva + BCG Details
24 study locations (See Clinicaltrials.gov for details)
Phase 2
x

BCG Naïve NMIBC CIS & Papillary

A Study of Intravesical BCG in Combination With ALT-803 in BCG Naïve Patients with High-Grade, 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 2
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:
LungMAP: N-803 + Pembro vs. SOC in Participants with Stage IV or Recurrent NSCLC
Anktiva + Keytruda (Pembrolizumab)Details
Southwest Oncology Group; LungMAP (See clinicaltrials.gov for list of trial sites)
Phase 2
x

LungMAP: N-803 + Pembro vs. SOC in Participants with Stage IV or Recurrent NSCLC

S1800: Phase II/III LungMAP trial to study how well immunotherapy treatment with N-803 and pembrolizumab works in treating patients with advanced NSCLC previously treated with Anti-PD-1 or Anti-PD-L1 therapy

NCT05096663

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Lung Cancer:
1L Non-Small Cell Lung Cancer Checkpoint + Concurrent Chemo
Anktiva + Keytruda (Pembrolizumab) Details
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

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
Hoag Memorial Presbyterian Hospital (Newport Beach, CA)
Phase 1
x

3L or Greater Triple Negative Breast Cancer

QUILT 3.058: A Study of Sacituzumab 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 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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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 1b
Advanced Solid Tumors:
Advanced Solid Tumors
M-ceNKDetails
Chan Soon-Shiong Institute for Medicine (El Segundo, CA); Hoag Memorial Presbyterian Hospital (Newport Beach, CA)
Phase 1
x

Advanced Solid Tumors

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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Infectious Diseases
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: COVID-19 Vaccine: hAd5 S+N USA (SC, SC)
hAd5 S+NDetails
Chan Soon-Shiong Institute for Medicine (El Segundo, CA); Hoag Memorial Presbyterian Hospital (Newport Beach, CA)
Phase 1c
x

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
Chan Soon-Shiong Institute for Medicine (El Segundo, CA); Hoag Memorial Presbyterian Hospital (Newport Beach, CA)
Phase 1c
x

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 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 South Africa (ProVIVA)
hAd5 S+NDetails
Khayelitsha Clinical Research Site, Site B Community Health Center, 98 Sulani Drive, Khayelitsha, 7784
Phase 1c
x

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

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 Boost: hAd5 S+N South Africa (Sisonke Boost)
hAd5 S+N Boost to J&J primeDetails
Khayelitsha Clinical Research Site, Site B Community Health Center, 98 Sulani Drive, Khayelitsha, 7784
Emavundleni Research Centre, 14 Sonwabile Drive, Old Crossroads, Cape Town, SA.
Phase 2c

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.