Clinical trials: sponsored by ImmunityBio, Inc.
Metastatic Solid Tumor
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 Suspension for Infusion, Cryopreserved, and N-803 for subcutaneous administration in subjects with locally advanced or metastatic…
- Trial name
- NCT04898543
- Testing
- M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B), N-803 (Cohort 2 part B), Apheresis collection of MNCs (part A)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- ImmunityBio, Inc.
NSCLC Stage IV
Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy
This is a randomized, two-cohort, open-label, phase 3, clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (cohort A) or prior failed Health Authority-approved antiprogrammed death-1 (PD-1)…
- Trial name
- NCT06745908
- Testing
- N-803, Tislelizumab, Docetaxel
- Where
- 49 sites in United States, Canada and 1 more
- Volunteers
- 507 people
- Sponsor
- ImmunityBio, Inc.
Pancreatic Cancer
Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
This is a phase 2, three-cohort (2 randomized and 1 single-arm), open-label study to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with…
- Trial name
- NCT04390399
- Testing
- N-803, Aldoxorubicin HCl, PD-L1 t-haNK
- Where
- 4 sites in United States
- Volunteers
- 328 people
- Sponsor
- ImmunityBio, Inc.
Sepsis
NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis
This Phase 2a study will evaluate the safety and efficacy of nogapendekin alfa inbakicept (NAI) plus standard of care compared with placebo plus standard of care in critically ill adults with sepsis and persistent lymphopenia.
- Trial name
- NCT07783789
- Testing
- Nogapendekin alfa inbakicept (NAI)
- Volunteers
- 50 people
- Sponsor
- ImmunityBio, Inc.
Long COVID, Long COVID Syndrome
A Study to Examine Anktiva for the Treatment of COVID-19.
This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.
- Conditions
- Long COVID, Long COVID Syndrome, Long Covid 19
- Trial name
- NCT07123727
- Testing
- Anktiva
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
Metastatic Urothelial Carcinoma, Urothelial Carcinoma
N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer
This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced)…
- Conditions
- Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Urothelial Cancer
- Trial name
- NCT07217496
- Testing
- Nogapendekin Alfa Inbakicept (NAI), enfortumab vedotin (EV), Pembrolizumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- ImmunityBio, Inc.
HPV-Related Carcinoma
IBRX-042 In Participants With HPV-Associated Tumors
The goal of this clinical trial is to determine the maximum tolerated dose and to find out the side effects of a drug called IBRX-042 at different dose levels in patients with recurrent or progressive Human Papillomavirus (HPV)…
- Trial name
- NCT05976828
- Testing
- IBRX-042
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- ImmunityBio, Inc.
Pancreatic Cancer Resectable, Pancreatic Cancer
Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer
This is an open-label, phase 1 clinical trial to evaluate the safety and preliminary efficacy of neoadjuvant chemoimmunotherapy (NAI, sotevtamab, and zabadinostat in combination with gemcitabine and nab-paclitaxel) followed by…
- Trial name
- ResQ108B-PANC (NCT07488884)
- Testing
- Nogapendekin Alfa Inbakicept (N803), Sotevtamab, Zabadinostat (CXD101)
- Sponsor
- ImmunityBio, Inc.
B-ALL, Leukemia
A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia
This is a phase 1, open-label study to evaluate the safety and efficacy of CD19 t-haNK in patients with B-cell acute lymphoblastic leukemia. Up to 10 patients will receive at least 1 dose of study drug.
- Trial name
- NCT07556757
- Testing
- CD19 t-haNK
- Where
- 2 sites in South Africa
- Volunteers
- 4 people
- Sponsor
- ImmunityBio, Inc.
Non-Hodgkin Lymphoma Refractory/ Relapsed
Study for Participants With Relapsed/Refractory Non-Hodgkin Lymphoma
Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL).
- Trial name
- NCT06334991
- Testing
- CD19 t-haNK
- Where
- 3 sites in South Africa
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
Glioblastoma
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma
This study consists of 2 portions. The phase 2 portion is an open-label, single-arm study to evaluate the safety and efficacy of NAI, PD-L1 t-haNK, and bevacizumab combination therapy in participants with recurrent or progressive…
- Trial name
- NCT06061809
- Testing
- Bevacizumab, PD-L1 t-haNK, N-803
- Where
- 4 sites in United States
- Volunteers
- 34 people
- Sponsor
- ImmunityBio, Inc.
Platinum-resistant Ovarian Cancer
A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer
This is phase 2 single arm study evaluating the safety and preliminary efficacy of M-CENK adoptive cell therapy and fixed dose of N-803 in combination with gemcitabine in participants with platinum-resistant high-grade ovarian…
- Trial name
- NCT06710288
- Testing
- Gemcitabine, N-803, M-CENK
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
NSCLC (Advanced Non-small Cell Lung Cancer), Metastatic NSCLC
Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC
This is a randomized, open-label, phase 3 study evaluating nogapendekin alfa inbakicept (NAI) plus chemoimmunotherapy containing pembrolizumab and platinum-based chemotherapy versus chemoimmunotherapy alone as first-line…
- Trial name
- NCT07524257
- Testing
- Drug: Nogapendekin alfa inbakicept (NAI), Pembrolizumab, Cisplatin or Carboplatin
- Sponsor
- ImmunityBio, Inc.
HPV-Positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma
Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation
This Phase 2a/2 study evaluates the safety, tolerability, and efficacy of neoadjuvant and adjuvant NAI, hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel in participants with locally advanced HPV-positive oropharyngeal squamous…
- Conditions
- HPV-Positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Head and Neck Cancer
- Trial name
- NCT07628062
- Testing
- Nogapendekin Alfa Inbakicept (NAI), hAd5-HPV Vaccine (IBRX-042), Nab-Paclitaxel
- Volunteers
- 70 people
- Sponsor
- ImmunityBio, Inc.
Non Small Cell Lung Cancer
Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer
This is a phase 3, open-label, 4-cohort study (3 randomized cohorts and 1 single-arm cohort). Participants enrolled in each cohort will be treated as detailed below. Each study cohort will be analyzed separately.
- Trial name
- NCT03520686
- Testing
- NAI + Pembrolizumab, NAI + Nivolumab + Ipilimumab, NAI + Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel
- Where
- 31 sites in United States
- Volunteers
- 102 people
- Sponsor
- ImmunityBio, Inc.
NMIBC
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1…
- Trial name
- NCT07551544
- Testing
- BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg)
- Sponsor
- ImmunityBio, Inc.
NMIBC
ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer
This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are…
- Trial name
- NCT06810141
- Testing
- rMBCG
- Where
- 66 sites in United States
- Sponsor
- ImmunityBio, Inc.
Long COVID
A Study to Assess Anktiva in Patients With Long Covid-19.
This study will test the safety and tolerability of Anktiva in patients with Long Covid. Eligible patients will receive up to 2 doses of Anktiva and have follow-up exams and tests.
- Trial name
- INTERRUPT_LC (NCT07108036)
- Testing
- N-803 (IL-15 Superagonist)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
Sepsis, Septic Shock
NAI for Sepsis With Persistent Lymphopenia
This is a Phase 2, randomized, open-label study evaluating the safety and efficacy of nogapendekin alfa inbakicept (NAI, ANKTIVA®) in combination with standard of care versus standard of care alone in critically ill adults with…
- Conditions
- Sepsis, Septic Shock, Lymphopenia, Immunosuppression
- Trial name
- NCT07578558
- Testing
- Nogapendekin alfa inbakicept (NAI), Standard of Care (SOC)
- Volunteers
- 50 people
- Sponsor
- ImmunityBio, Inc.
Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS)
Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia
This is a Phase 3, randomized, blinded, and placebo-controlled clinical trial investigating a new combination treatment for critically ill adults who have severe community-acquired pneumonia, especially if they also have sepsis…
- Conditions
- Community-Acquired Pneumonia (CAP), Acute Respiratory Distress Syndrome (ARDS), Sepsis, Lymphopenia
- Trial name
- NCT07492875
- Testing
- Nogapendekin alfa inbakicept (NAI), agenT-797
- Sponsor
- ImmunityBio, Inc.