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/ ImmunityBio
- LARVOL DELTA
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February 21, 2025
QUILT-3.091 NANT Chordoma Vaccine vs Radiation in Subjects With Unresectable Chordoma.
(clinicaltrials.gov)
- P1/2 | N=0 | Withdrawn | Sponsor: ImmunityBio, Inc. | Phase classification: P1b/2 ➔ P1/2
Phase classification • Chordoma • Oncology • Solid Tumor
December 11, 2024
QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine
(clinicaltrials.gov)
- P1/2 | N=2 | Terminated | Sponsor: ImmunityBio, Inc. | Phase classification: P1b/2 ➔ P1/2 | N=332 ➔ 2 | Active, not recruiting ➔ Terminated; low enrollment
Enrollment change • Metastases • Phase classification • Trial termination • Colorectal Cancer • Oncology • Solid Tumor
December 12, 2024
QUILT-3.060t: QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
(clinicaltrials.gov)
- P1/2 | N=6 | Terminated | Sponsor: ImmunityBio, Inc. | N=80 ➔ 6 | Unknown status ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial termination • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor
August 27, 2024
QUILT-3.080: NANT Pancreatic Cancer Vaccine
(clinicaltrials.gov)
- P1/2 | N=3 | Terminated | Sponsor: ImmunityBio, Inc. | Phase classification: P1b/2 ➔ P1/2 | N=173 ➔ 3 | Unknown status ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Phase classification • Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor
August 05, 2024
QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed
(clinicaltrials.gov)
- P1/2 | N=4 | Terminated | Sponsor: ImmunityBio, Inc. | N=65 ➔ 4 | Unknown status ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial termination • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck
August 09, 2024
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
(clinicaltrials.gov)
- P1/2 | N=9 | Terminated | Sponsor: ImmunityBio, Inc. | N=79 ➔ 9 | Trial completion date: Oct 2023 ➔ Jan 2024 | Active, not recruiting ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR
May 22, 2024
QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
(clinicaltrials.gov)
- P1/2 | N=4 | Terminated | Sponsor: ImmunityBio, Inc. | N=173 ➔ 4 | Unknown status ➔ Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor
September 28, 2023
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
(clinicaltrials.gov)
- P1/2 | N=79 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Jan 2023 ➔ Oct 2023 | Trial primary completion date: Dec 2022 ➔ Sep 2023
Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR
March 29, 2022
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
(clinicaltrials.gov)
- P1/2 | N=79 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Jan 2020 ➔ Jan 2023 | Trial primary completion date: Dec 2019 ➔ Dec 2022
Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR
March 29, 2022
QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine
(clinicaltrials.gov)
- P1b/2 | N=332 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022
Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor
October 08, 2021
QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy
(clinicaltrials.gov)
- P2; N=9; Terminated; Sponsor: ImmunityBio, Inc.; N=43 ➔ 9; Trial completion date: Mar 2022 ➔ Oct 2021; Recruiting ➔ Terminated; Trial primary completion date: Mar 2022 ➔ Oct 2021; Not meeting recruitment goal
Checkpoint inhibition • Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Solid Tumor
December 29, 2017
Molecularly Informed Integrated Immunotherapy Combining Innate haNK Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti- PD-1/ PD-L1 Therapy
(clinicaltrials.gov)
- P1/2; N=65; Recruiting; Sponsor: NantKwest, Inc.
Clinical • New P1/2 trial • Biosimilar • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
December 21, 2020
ImmunityBio and NantKwest to Merge, Creating a Leading Immunotherapy and Cell Therapy Company
(NantKwest)
- "Broad late-stage pipeline for solid tumors including bladder, lung, breast, and pancreatic in addition to infectious disease programs for HIV and COVID-19; ImmunityBio...today announced they have entered into an agreement to merge in a stock-for-stock transaction. The combination will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease."
M&A • Infectious Disease • Novel Coronavirus Disease
November 07, 2019
NantKwest announces presentation of positive phase 2 clinical data of natural killer cell therapy in metastatic merkel cell carcinoma at SITC 2019
(Businesswire)
- P2, N=43; NCT03853317; Sponsor: NantKwest; "NantKwest...announced the presentation of results from their Phase 2 trial investigation using aNK, NantKwest’s off-the-shelf natural killer cell-based therapeutic, in combination with N-803, ImmunityBio’s IL-15 superagonist, in patients with advanced refractory metastatic Merkel cell carcinoma (MCC) (NCT03853317) at The 34th Annual Meeting of the Society for Immunotherapy for Cancer (SITC 2019) on November 8, 2019 in National Harbor, Maryland. ImmunityBio is an affiliate company of NantKwest....Dr. Shailender Bhatia...will make an oral presentation entitled 'Final results from a phase 2 study using off-the-shelf activated natural killer (aNK) cells in combination with N-803, an IL-15 superagonist, in patients with metastatic Merkel cell carcinoma (MCC).'"
Media quote • P2 data • Merkel Cell Carcinoma • Oncology
February 05, 2018
CytRx Corporation highlights second NantCell Inc. clinical trial evaluating immuno-oncology agents and cell-based therapies in combination with aldoxorubicin in patients with advanced squamous cell carcinoma
(PRNewswire)
- P1/2, N=65; NCT03387111; "CytRx Corporation...today highlighted that aldoxorubicin licensee NantCell...has dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with advanced squamous cell carcinoma (SCC) of either the head and neck or non-small cell lung cancer. This...will investigate high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in certain high unmet need cancer indications."
Enrollment open • Oncology
April 14, 2020
NantKwest and ImmunityBio announce therapeutics and vaccines for combatting Covid-19; clinical trials anticipated to begin this quarter
(Businesswire)
- “'In the mild-to-moderate stage of infection, we believe that the patient’s infection and viral load could be mitigated with natural killer (NK) and T cell stimulation. Hence, in this early-moderate stage of the disease, we are proposing clinical trials of N-803 alone, and a second trial of haNK alone, or haNK combined with convalescent plasma'....Investigational New Drug (IND) applications with the FDA for these trials are pending....NantKwest has filed an IND with the FDA and anticipates beginning trials in Q2 2020."
IND • New trial • Infectious Disease • Novel Coronavirus Disease
December 16, 2019
NantKwest and ImmunityBio present results of landmark trial of first-in-human natural killer cell combination immunotherapy with durable, complete response data and 78% disease control in refractory triple negative breast cancer at SABCS
(Businesswire)
- P1b, N=79; QUILT-3.067 (NCT03387085); Sponsor: NantKwest, Inc; “Ongoing durable complete responses ranging from 8 to 11 months observed in TNBC patients who failed standard of care. Disease control rate of 78% and overall response rate of 67% in heavily pretreated patients. Median progression free survival exceeds 13 months compared to historical controls of 2-3 months in advanced third-line setting. Ongoing survival to date of 78% of patients ranging from 2 to 12 months…. No immune related SAEs were attributed to the immunotherapy investigational agents. All patients had at least 1 grade ≥ 3 TRAE, primarily chemotherapy-related neutropenia or anemia. Grade ≥ 3 haNK-related AEs, namely fever and fatigue, were observed in 2 patients.”
P1 data
November 27, 2019
NantKwest hosting key opinion leader meeting on novel immunotherapeutic approaches to address the unmet medical needs of patients with merkel cell carcinoma, triple-negative breast cancer and solid tumors
(Businesswire)
- "NantKwest, Inc...announced that on Monday, December 2, 2019, it will host a key opinion leader (KOL) meeting in New York City on the current treatment landscapes and unmet medical needs of patients with Merkel cell carcinoma, triple-negative breast cancer, solid tumors and the state-of-the-art treatment in the induction of Immunogenic Cell Death....NantKwest’s management team will also provide pipeline updates on their haNK and PD-L1.t-haNK programs utilizing the Company’s Activated Natural Killer (aNK) cell platform to target these diseases."
Clinical
June 24, 2019
NantKwest launches first-in-class, first-in-human phase I clinical trial with a targeted PD-L1 t-haNK cell therapy in patients with solid tumors
(Businesswire)
- “NantKwest Inc….announced that the company’s PD-L1 t-haNK investigational new drug application (IND) has cleared FDA review and the program has now transitioned to a first-in-human clinical trial in patients with locally advanced or metastatic solid cancers.”
IND • New P1 trial
January 09, 2019
NantKwest announces launch of Merkel cell carcinoma phase II trial deploying novel triple combination of off-the-shelf natural killer haNK cell therapy with superagonist IL-15 cytokine therapy and PD-L1 checkpoint inhibitor therapy
(Businesswire)
- "NantKwest Inc...today announced the launch of a novel triple combination, phase II clinical trial in Merkel cell carcinoma (MCC)...In this new clinical trial, patients will be dosed with: (i) the novel chemotherapy-free combination of our haNK cell therapy, which are aNK cells that are genetically engineered to express the high-affinity variant of the CD16 receptor (V158 FcγRIIIa), (ii) avelumab, a PD-L1 targeting checkpoint inhibitor, and (iii) N-803, a superagonist IL-15/Fc cytokine therapy, in a regimen designed to synergistically optimize the therapeutic potential of each agent."
New P2 trial
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