Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-04 @ 4:09 PM
Study NCT ID:
NCT03503968
Status:
TERMINATED
Last Update Posted:
2023-02-15
First Post:
2018-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms
Sponsor:
Medigene AG
Organization:
Study Overview
Official Title:
A Phase I/II, Open-Label, Non-Randomized, Multicentre, Dose-Escalation Clinical Trial With Control Group to Evaluate the Safety, Feasibility and Preliminary Efficacy of PRAME TCR Modified T Cells, MDG1011, in Subjects With High Risk Myeloid and Lymphoid Neoplasms
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The clinical trial is terminated after the completion of phase I without moving to Phase II.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicentre, non-randomized, open-label, Phase I/II clinical trial of MDG1011, an investigational medicinal product (IMP), consisting of patient-derived autologous T cells, persistently transduced with a Preferentially Expressed Antigen in Melanoma (PRAME)-specific human leukocyte antigen (HLA)-A\*02:01-restricted T cell receptor (TCR).
Detailed Description:
Phase I:
The Phase I dose escalation part will establish the MTD/RP2D in subjects with high risk myeloid and lymphoid neoplasms, a total of 3 disease entities.
Phase I subjects will be enrolled into the following cohorts and treated with a single intravenous (i.v.) infusion of IMP:
* Cohort 1: target dose of 1 x 105 T cells/kg ± 20%
* Cohort 2: target dose of 1 x 106 T cells/kg ± 20%
* Cohort 3: target dose of 5 x 106 T cells/kg ± 20%
* Optional cohort 4: up to 1 x 107 T cells/kg + 20%
Phase II:
The Phase II part consists of two arms, each representing one disease entity. Within each arm, representing a disease entity, subjects will be enrolled in 2 different treatment groups to receive either:
1. IMP in the treatment group (up to 20 subjects who are positive for human leukocyte antigen (HLA)-A\*02:01); Or
2. therapy as per Investigator's discretion in the concurrent control (up to 20 subjects who are negative for HLA-A\*02:01).
The Phase I dose escalation part will establish the MTD/RP2D in subjects with high risk myeloid and lymphoid neoplasms, a total of 3 disease entities.
Phase I subjects will be enrolled into the following cohorts and treated with a single intravenous (i.v.) infusion of IMP:
* Cohort 1: target dose of 1 x 105 T cells/kg ± 20%
* Cohort 2: target dose of 1 x 106 T cells/kg ± 20%
* Cohort 3: target dose of 5 x 106 T cells/kg ± 20%
* Optional cohort 4: up to 1 x 107 T cells/kg + 20%
Phase II:
The Phase II part consists of two arms, each representing one disease entity. Within each arm, representing a disease entity, subjects will be enrolled in 2 different treatment groups to receive either:
1. IMP in the treatment group (up to 20 subjects who are positive for human leukocyte antigen (HLA)-A\*02:01); Or
2. therapy as per Investigator's discretion in the concurrent control (up to 20 subjects who are negative for HLA-A\*02:01).
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?: