Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT02459067
Status:
TERMINATED
Last Update Posted:
2022-03-10
First Post:
2015-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ImmuniCell® in Patients With Advanced Cancers
Sponsor:
TC Biopharm
Organization:
Study Overview
Official Title:
Adaptive Study of the Safety, Tolerability & Efficacy of Autologous γδ T Lymphocyte Therapy (ImmuniCell®) in Patients With Advanced Cancers Refractory to Current Treatment or Have Indolent Disease for Which Immunotherapy May be Beneficial
Status:
TERMINATED
Status Verified Date:
2022-03
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:
To determine the safety, tolerability, maximum tolerated dose (MTD) and efficacy of ImmuniCell® in patients with melanoma, renal cell cancer (RCC) or non-small cell lung cancer (NSCLC). The study is an adaptive design that has 3 stages: Stage 1 - dose escalation, Stage 2 - efficacy, and Stage 3 - confirm efficacy in one of the tumor types.
Detailed Description:
This is an open-label trial of ImmuniCell® treatment of patients with malignant melanoma, renal cell cancer (RCC) or non-small cell lung cancer (NSCLC) which are refractory to current treatment or who have indolent disease for which immunotherapy may be beneficial. The trial is designed to identify a safe dose of ImmuniCell® for future clinical trials, to identify a response signal from one or more of the cancers under investigation and to confirm the safety and efficacy in the selected target tumour.
The trial has three stages:
Stage I comprising a safety cohort of patients to identify a safe dose Stage II comprising an expanded patient group for response signal identification Stage III to confirm efficacy and safety.
The trial has three stages:
Stage I comprising a safety cohort of patients to identify a safe dose Stage II comprising an expanded patient group for response signal identification Stage III to confirm efficacy and safety.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: