Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-28 @ 11:12 PM
Study NCT ID:
NCT03574168
Status:
UNKNOWN
Last Update Posted:
2018-06-29
First Post:
2018-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19-CAR-T Cells in Patients With R/R B-ALL
Sponsor:
Bioceltech Therapeutics, Ltd.
Organization:
Study Overview
Official Title:
Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
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:
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Detailed Description:
Primary objective:
To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.
Secondary objective:
To Assess the patient's quality of life after receiving the treatment.
To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.
Secondary objective:
To Assess the patient's quality of life after receiving the treatment.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ChiCTR1800016541 | REGISTRY | Chinese Clinical Trial Registry | View |