Clinical trials: sponsored by 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.
Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum
Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS)
This Phase 2 study tests whether adding two immune therapies - nogapendekin alfa-inbakicept (NAI) and off-the-shelf iNKT cell infusions - to standard care can safely help critically ill adults with severe community-acquired…
- Conditions
- Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum, Sepsis, Lymphopenia / Immunoparalysis in Critically Ill Adults
- Trial name
- NCT07492888
- Testing
- Nogapendekin Alfa-Inbakicept (NAI), Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797)
- Sponsor
- ImmunityBio, Inc.
High-risk Prostate Cancer
Immunotherapy Before and After Surgery
This Phase 2 clinical trial is testing a new immunotherapy combination (N-803, ETBX-071, M-CENK) for men with high-risk prostate cancer before and after prostate surgery.
- Trial name
- NCT06765902
- Testing
- N-803, ETBX-071, M-CENK
- Sponsor
- ImmunityBio, Inc.
High-risk Prostate Cancer
Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.
This study tests a new treatment for men with high-risk prostate cancer who can't have surgery. The treatment combines three experimental drugs and radiation therapy.
- Trial name
- NCT06765954
- Testing
- N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus), M-CENK (Activated NK Cells)
- Sponsor
- ImmunityBio, Inc.
Relapsed B-Cell Non Hodgkin Lymphoma
Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma
Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination with Rituximab in subjects with Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.
- Trial name
- NCT07125872
- Testing
- CD19 t-haNK- IV Administration
- Where
- 2 sites in South Africa
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
Non Muscle Invasive Bladder Cancer
Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
The purpose of this clinical trial is to obtain long-term follow-up information and status of bladder cancer for patients who received study treatment in the QUILT-2.005 study.
- Trial name
- NCT05981131
- Testing
- N803 plus Bacillus Calmette-Guerin (BCG)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- ImmunityBio, Inc.
Advanced Pancreatic Carcinoma
HCW9218 for Advanced Pancreatic Cancer
This is a Phase 1b/2, open-label, multi-center, competitive enrollment and dose-escalation study of HCW9218 in patients with advanced/metastatic pancreatic cancer.
- Trial name
- NCT05304936
- Testing
- HCW9218, Gemcitabine (GEM), Nab-paclitaxel
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- ImmunityBio, Inc.
B-cell Non Hodgkin Lymphoma
N-803 Maintenance Therapy Post CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas
The purpose of this clinical trial is to learn whether the study drug N-803 is safe and tolerable in patients with B-cell non-Hodgkin lymphoma who have undergone CAR T-cell therapy.
- Trial name
- CARMEN-803 (NCT07049432)
- Testing
- N803
- Where
- United States
- Sponsor
- University of Utah
Non Hodgkin's Lymphoma Refractory/Relapsed
Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma
Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma.
- Trial name
- NCT05618925
- Testing
- N803, CD19t-haNK suspension, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
Locally Advanced Solid Tumor, Metastatic Cancer
QUILT-3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers
Phase 1 study to assess the safety, preliminary efficacy of PD-L1 t-haNK and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers.
- Conditions
- Locally Advanced Solid Tumor, Metastatic Cancer, Solid Tumor
- Trial name
- NCT04050709
- Testing
- PD-L1 t-haNK
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- ImmunityBio, Inc.
Non-muscle Invasive Bladder Cancer
A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
- Trial name
- NCT02138734
- Testing
- BCG (50mg/instillation) + N-803 (400 μg/instillation), BCG (50mg/instillation)
- Where
- 108 sites in United States, India and 1 more
- Volunteers
- 369 people
- Sponsor
- ImmunityBio, Inc.
NMIBC
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus…
- Trial name
- NCT06800963
- Testing
- Intravesical Recombinant Mycobacterium (rMBCG)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
Relapsed B-Cell Non-Hodgkin Lymphoma
Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma
Open-Label, Phase 2 Chemotherapy-Free Study ofCD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Indolent Non-Hodgkin Lymphoma.
- Trial name
- NCT07477366
- Testing
- CD19 t-haNK- IV Administration, N-803, rituximab
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
Non-Small Cell Lung Cancer, Small Cell Lung Cancer
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors
QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors.
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Urothelial Carcinoma, Head and Neck Squamous Cell Carcinoma
- Trial name
- NCT03228667
- Testing
- N-803 + Pembrolizumab, N-803 + Nivolumab, N-803 + Atezolizumab
- Where
- 35 sites in United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
Bladder Cancer
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC).
- Trial name
- NCT03022825
- Testing
- N-803 and BCG, N-803
- Where
- 28 sites in United States
- Volunteers
- 190 people
- Sponsor
- ImmunityBio, Inc.