10 completed, 6 terminated, 2 withdrawn. 15 Phase 1, 8 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 9, Terminated 5, Withdrawn 1 |
| Phase 2 | 8 | Terminated 4, Completed 3, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| CIML NK Cell in Head & Neck Cancer Interleukin-15 Superagonist (N-803), CIML NK cell Infusion, Ipilimumab - Squamous Cell Carcinoma of the Head and Neck, Recurrent Head and Neck Squamous Cell Carcinoma | Phase 1 | Completed | Dana-Farber Cancer Institute | 11 | 2020-07-20 | 2026-07-30 |
| PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14) BCG in Combination with N-803, N-803 alone - Pharmacokinetics | Terminated | Altor BioScience | 1 | 2019-12-09 | 2024-12-10 | |
| 2015-10: Expanded Natural Killer Cells and Elotuzumab for High-Risk Myeloma Post- Autologous Stem Cell Transplant (ASCT) Elotuzumab, Melphalan, Autologous Stem Cell Transplant (ASCT) - Multiple Myeloma | Phase 2 | Withdrawn | University of Arkansas | 2019-11-01 | 2020-07-10 | |
| QUILT-1.004: A Single Center, Open-label, Pharmacokinetic Study of Subcutaneous ALT-803 ALT-803 - Healthy | Phase 1 | Completed | Altor BioScience | 20 | 2017-12-27 | 2025-03-24 |
| QUILT-2.001: ALT-803 in Patients With Advanced Pancreatic Cancer in Conjunction With Gemcitabine and Nab-Paclitaxel Gemcitabine, Nab-paclitaxel, ALT-803 - Advanced Pancreatic Cancer | Phase 1 | Completed | Altor BioScience | 8 | 2016-07-01 | 2020-01-27 |
| ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer ALT-803, Nivolumab - Non-small Cell Lung Cancer | Phase 1 / Phase 2 | Completed | Medical University of South Carolina | 67 | 2016-01-08 | 2026-02-17 |
| QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab Rituximab, N-803 - Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphoma | Phase 1 / Phase 2 | Terminated | Altor BioScience | 43 | 2015-04-17 | 2024-07-03 |
| QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma N-803 - Relapsed or Refractory Multiple Myeloma | Phase 1 | Terminated | Altor BioScience | 19 | 2014-10-06 | 2024-09-26 |
| A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors ALT-803 - Advanced Solid Tumors | Phase 1 | Completed | Altor BioScience | 26 | 2014-05-01 | 2025-01-22 |
| QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma ALT-801 - Relapsed or Refractory Multiple Myeloma | Phase 1 / Phase 2 | Terminated | Altor BioScience | 6 | 2012-08-14 | 2024-06-18 |
| A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer ALT-801, Gemcitabine - Non-muscle Invasive Bladder Cancer | Phase 1 / Phase 2 | Terminated | Altor BioScience | 12 | 2012-03-30 | 2024-07-19 |
| ALT-801-activated Natural Killer Cells After FLAG Induction for Acute Myeloid Leukemia G-CSF, Cytarabine, Fludarabine - Acute Myeloid Leukemia | Phase 1 | Withdrawn | Altor BioScience | 2011-11-01 | 2014-01-03 | |
| A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer Cisplatin, Gemcitabine, ALT-801 - Transitional Cell Carcinoma of Bladder, Urethra Cancer | Phase 1 / Phase 2 | Completed | Altor BioScience | 68 | 2011-09-06 | 2024-06-25 |
| A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors ALT-836 in combination with gemcitabine - Locally Advanced Malignant Neoplasm, Malignant Solid Tumour | Phase 1 | Completed | Altor BioScience | 30 | 2011-05-01 | 2016-07-15 |
| QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma Cisplatin, ALT-801 - Metastatic Melanoma | Phase 1 / Phase 2 | Terminated | Altor BioScience | 22 | 2010-02-01 | 2026-09-10 |
| Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome ALT-836, Placebo - Sepsis, Acute Lung Injury | Phase 2 | Completed | Altor BioScience | 150 | 2009-04-01 | 2015-04-10 |
| Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies ALT-801 - Progressive Metastatic Malignancies | Phase 1 | Completed | Altor BioScience | 26 | 2007-05-01 | 2013-07-22 |
| Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome TNX-832, Placebo - Sepsis, Acute Lung Injury | Phase 1 | Completed | Altor BioScience | 18 | 2004-12-01 | 2025-01-06 |
Neoplasms (10) · Neoplasm Metastasis (7) · Recurrence (4) · Melanoma (3) · Multiple Myeloma (3) · Urinary Bladder Neoplasms (3) · Acute Lung Injury (2) · Breast Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (2) · Colonic Neoplasms (2) · Head and Neck Neoplasms (2) · Lung Diseases (2) · Lymphoma (2) · Ovarian Neoplasms (2) · Respiratory Distress Syndrome (2)
ALT-803 (9) · ALT-801 (6) · Gemcitabine (4) · ALT-836 (3) · Cell Count (2) · Cisplatin (2) · 130-nm albumin-bound paclitaxel (1) · Albumin-Bound Paclitaxel (1) · Cetuximab (1) · Cytarabine (1) · Granulocyte Colony-Stimulating Factor (1) · Immune Checkpoint Inhibitors (1) · Ipilimumab (1) · Melphalan (1) · Nivolumab (1)
United States (18) · Canada (1)
Hing C Wong, PhD (3) · Hing Wong, PhD (2) · Chad Garner, PhD (1) · Frits van Rhee, MD, PhD (1) · Hing C. Wong, Ph.D. (1) · John Wrangle, MD (1) · Marc Ernstoff, MD (1) · Sarah Nikiforow, MD, PhD (1)
PMID 22340260, PMID 21994418, PMID 29628312, PMID 33832946, PMID 39948608
R44CA097550 (1), U01CA154967 (1)