Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-04 @ 11:45 PM
Study NCT ID:
NCT03302403
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2017-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors
Sponsor:
Kang YU
Organization:
Study Overview
Official Title:
Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR T cells in patients with malignant tumors with positive antigen targets.
CAR T cells are genetically engineered to express single-chain variable fragment (scFv) targeting indication-specific antigens.
The investigational CAR T cells and proposed indications are as follows:
CAR-CD19 T cells for B cell leukaemia/lymphoma; CAR-BCMA T cells for myeloma; CAR-GPC3 T cell for hepatocellular carcinoma; CAR-CLD18 T cells for pancreatic carcinoma and adenocarcinoma of esophagogastric junction.
CAR T cells are genetically engineered to express single-chain variable fragment (scFv) targeting indication-specific antigens.
The investigational CAR T cells and proposed indications are as follows:
CAR-CD19 T cells for B cell leukaemia/lymphoma; CAR-BCMA T cells for myeloma; CAR-GPC3 T cell for hepatocellular carcinoma; CAR-CLD18 T cells for pancreatic carcinoma and adenocarcinoma of esophagogastric junction.
Detailed Description:
This study is designed to determine the safety, tolerability and engraftment potential of lentivirus-transduced CAR T cells in patients with malignant tumors.
Primary objectives:
1. Determine the safety and tolerability of CAR T cells (autologous T cells transduced with chimeric antigen receptors recognizing CD19, BCMA, GPC3 and Claudin18.2) in patients with malignant tumors (B-cell lymphoblastic leukaemia/lymphoma, myeloma, hepatocellular carcinoma, pancreatic carcinoma and adenocarcinoma of esophagogastric junction).
2. Observe the cytokinetics of CAR T cells.
Secondary objectives:
1. Observe the efficacy of CAR T cells in patients with malignant tumors.
2. Make an evaluation on the distribution and in vivo survival of CAR T cells in targeted tissues.
3. Observe the immunogenicity of CAR T cells, and determine if there are anti-scFv cellular immune response and anti-scFv humoral immune response.
4. Observe the changes of cell subsets for CAR T cells against T cells (Tcm, central memory T lymphocytes; Tem, effector memory T lymphocytes; Treg, regulatory T-lymphocytes).
Primary objectives:
1. Determine the safety and tolerability of CAR T cells (autologous T cells transduced with chimeric antigen receptors recognizing CD19, BCMA, GPC3 and Claudin18.2) in patients with malignant tumors (B-cell lymphoblastic leukaemia/lymphoma, myeloma, hepatocellular carcinoma, pancreatic carcinoma and adenocarcinoma of esophagogastric junction).
2. Observe the cytokinetics of CAR T cells.
Secondary objectives:
1. Observe the efficacy of CAR T cells in patients with malignant tumors.
2. Make an evaluation on the distribution and in vivo survival of CAR T cells in targeted tissues.
3. Observe the immunogenicity of CAR T cells, and determine if there are anti-scFv cellular immune response and anti-scFv humoral immune response.
4. Observe the changes of cell subsets for CAR T cells against T cells (Tcm, central memory T lymphocytes; Tem, effector memory T lymphocytes; Treg, regulatory T-lymphocytes).
Study Oversight
Has Oversight DMC:
True
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?: