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.
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody)…
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
- Trial name
- NCT06239220
- Testing
- PD-L1 t-haNK, Cetuximab, NAI
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Dana-Farber Cancer Institute
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.
Acute Myeloid Leukemia
Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation
This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia free survival to 30% from <10% expected with the use of reduced intensity haplo-HCT in this extremely high-risk patient cohort (based on…
- Trial name
- NCT02782546
- Testing
- Graft cell infusion, Tacrolimus, Mycophenolate mofetil
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Washington University School of Medicine
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.
HIV Infection
Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic…
- Trial name
- NCT04340596
- Testing
- N-803 (IL-15 Superagonist), VRC07-523LS, 10-1074
- Where
- 14 sites in United States
- Volunteers
- 118 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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.
Prostate Cancer, Metastatic Prostate Cancer
Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer
This phase Ib single-center open-label de-escalation study uses a modified 3+3 design to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of standard of care Sip-T and N-803 in patients…
- Trial name
- NCT07756593
- Testing
- Sipuleucel-T, N803
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Washington University School of Medicine
Urothelial Carcinoma, Bladder Cancer
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Upon successful screening and registration, enrollment to a cohort will begin. If DLT criteria are exceeded in a cohort, that cohort will close and will not proceed to Phase 2 of the study.
- Trial name
- ADAPT-BLADDER (NCT03317158)
- Testing
- Durvalumab (Cohort 1-3), External Beam Radiotherapy (EBRT), Bacillus Calmette-Guérin (BCG)
- Where
- 9 sites in United States
- Volunteers
- 186 people
- Sponsor
- Noah Hahn, M.D.
Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Recurrent
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
This is a single center, phase Ib/II study combining an anti-PD-1 antibody and an anti-CTLA-4 antibody with IL-15. It is testing the hypothesis that the addition of nogapendekin alfa inbakicept to nivolumab and ipilimumab will…
- Trial name
- FLINN (NCT07355205)
- Testing
- Ipilimumab, Nivolumab, Nogapendekin alfa inbakicept
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Washington University School of Medicine
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.