Clinical trials: sponsored by 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.
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.
Non-muscle Invasive Bladder Cancer (NMIBC)
Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease.
- Trial name
- NCT06829823
- Testing
- N-803 and BCG, N-803 and Gemcitabine
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
Lymphopenia
Expanded Access Use of Nogapendekin-alfa Inbakicept in the Reversal and Maintenance of Absolute Lymphocyte Count (ALC) for the Treatment of Lymphopenia Induced by Chemotherapy, Immunotherapy, and/or Radiation Therapy
This is a protocol for expanded access use of nogapendekin-alfa inbakicept (NAI) in participants with lymphopenia induced by chemotherapy, immunotherapy, and/or radiation therapy who may benefit from its use, and who are…
- Trial name
- NCT06956547
- Testing
- nogapendekin-alfa inbakicept
- Where
- United States
- Sponsor
- ImmunityBio, Inc.
Healthy Subjects
Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis
This is phase 1 single cohort study evaluating the effects of N-803 administration on mononuclear cells (MNC) collected from healthy donors undergoing a procedure called apheresis.
- Trial name
- NCT06040918
- Testing
- N-803
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
COVID-19
THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines
This is a phase 1/2 open-label study assessing the safety, reactogenicity, and immunogenicity of saRNA COVID-19 boost vaccines in participants that have been previously vaccinated against or previously infected with COVID-19.
- Trial name
- NCT05370040
- Testing
- AAHI-SC2 Vaccine, AAHI-SC3 Vaccine, EUA or approved vaccine
- Where
- South Africa
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
Head and Neck Squamous Cell Carcinoma
QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with HNSCC who have progressed on or after previous chemotherapy and anti-PD-1/PD-L1 therapy.
- Trial name
- NCT03169764
- Testing
- Avelumab, Bevacizumab, Capecitabine
- Sponsor
- ImmunityBio, Inc.
Non Hodgkin Lymphoma
QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with with CD20-positive NHL who have progressed on or after rituximab therapy.
- Trial name
- NCT03169790
- Testing
- avelumab, bevacizumab, capecitabine
- Sponsor
- ImmunityBio, Inc.
Colorectal Cancer
QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with recurrent and metastatic CRC.
- Trial name
- NCT03169777
- Testing
- avelumab, bevacizumab, capecitabine
- Sponsor
- ImmunityBio, Inc.