Trials / Terminated
TerminatedNCT04489420
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
A Phase I Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) in Adults With Recurrent Glioblastoma Multiforme (GBM)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Celularity Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy for the systemic cohort (IV) (intravenous). The intratumoral cohort (IT) will not be giving lymphodepletion. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating recurrent glioblastoma multiforme.
Conditions
- Astrocytoma, Grade IV
- Giant Cell Glioblastoma
- Glioblastoma Multiforme
- Cyclophosphamide
- Immunosuppressive Agents
- Immunologic Factors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antiviral Agents
- Anti-infective Agents
- Analgesics, Non-narcotic
- Analgesics
- Sensory System Agents
- Peripheral Nervous System Agents
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CYNK001-IV | Planned Starting dose dor IV 1.2x10\^9 cells/dose |
| BIOLOGICAL | CYNK001-IT | Planned starting dose for IT 200 x10\^6 +/- 50 x10\^6 cells dose |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2021-08-10
- Completion
- 2021-08-10
- First posted
- 2020-07-28
- Last updated
- 2022-08-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04489420. Inclusion in this directory is not an endorsement.