Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378190
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-02-16
Brief Title:
Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor CAR T-cell Therapy Produced by a New Technology
Sponsor:
Instituto de Investigación Biomédica de Salamanca
Organization:
Instituto de Investigación Biomédica de Salamanca
Study Overview
Official Title:
Multicentre Phase IIIa Study of Infusion of Autologous Peripheral Blood T Lymphocytes Expanded and Genetically Modified Using Sleeping Beauty Family Transposons to Express a Chimeric Antigenic Receptor With Anti-CD19 Specificity Conjugated to the 4-1BB Co-stimulatory Region and CD3z and huEGFRt Signal Transmission TranspoCART19 in Patients With Relapsed or Refractory B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-02
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:
TranspoCART19
Brief Summary:
The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsedrefractory B-lymphoma The main questions it aims to answer are
Maximum tolerated dose MTD Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months
Maximum tolerated dose MTD Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months
Detailed Description:
This clinical trial is a Phase III pilot open-label national prospective multicentre non-randomised open-label study to evaluate the safety and efficacy of TranspoCART19 in patients with relapsedrefractory B-lymphoma whose prognosis is less than 2 years
Phase I Dose escalation phase with a classic 33 design in which three dose levels of TranspoCART19 will be evaluated 1 x 106 cellskg 3 x106 cellskg and 5 x 106 cellskg The maximum number of patients included in this phase will be 18
Phase II an expansion cohort with the maximum tolerated dose MTD determined in Phase I
Patients will be included in the expansion cohort up to a total of 27 including Phase I patients
Phase I Dose escalation phase with a classic 33 design in which three dose levels of TranspoCART19 will be evaluated 1 x 106 cellskg 3 x106 cellskg and 5 x 106 cellskg The maximum number of patients included in this phase will be 18
Phase II an expansion cohort with the maximum tolerated dose MTD determined in Phase I
Patients will be included in the expansion cohort up to a total of 27 including Phase I patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-001040-23 | EUDRACT_NUMBER | None | None |