Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616209
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2020-10-08
Brief Title:
Allogeneic PB103 NK Cells Therapy in Non-small Cell Lung Cancer NSCLC Patients
Sponsor:
Precision Biotech Taiwan Corp
Organization:
Precision Biotech Taiwan Corp
Study Overview
Official Title:
A Phase Ι IIa Open-label Study to Evaluate Safety and Efficacy of the Combination Therapy of Allogeneic PB103 and Standard Cancer Treatment in the IIIBIV or Recurrent Non-small Cell Lung Cancer NSCLC Patients
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives To determine the safety tolerability and efficacy of allogeneic PB103 in patients with IIIbIV or refractory non-small-cell lung cancer
Detailed Description:
PB103 is allogeneic NK cells derived from a healthy donor In this phase IIIa trial patients with IIIbIV and refractory non-small cell lung cancer will be enrolled for testing the safety tolerability and efficacy of PB103 NK cells For assessment of safety and maximum tolerated dose MTD of PB103 three-dose levels of PB103 will be administered to enrolled patients based on the 33 dose-escalation design MTD is defined as one dose level below the dose at which dose-limiting toxicities DLT is observed in 33 of the participants DLT is defined as grade 4 toxicities hematological toxicities grade 3 toxicities non-hematological toxicities or acute GvHD more than grade 2 Once MTD is determined 12 patients at MTD dose will be enrolled for assessment of safety and efficacy of PB103 at phase IIa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None