Clinical Trial: NCT03870945
Safety of MB-CART2019.1 in Lymphoma Patients (MB-CART2019.1 Lymphoma / DALY 1)
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Miltenyi Biomedicine GmbH |
| Information Provided By: | Miltenyi Biomedicine GmbH |
| Last Update Posted: | 2025-05-28 |
Study Overview
Brief Summary
This is a prospective, multi-center, open phase I/II trial to evaluate feasibility, dosage, safety and toxicity as well as efficacy of ex vivo expanded autologous T cells genetically modified to express anti-CD20 and CD19 immunoreceptor (MBCART2019.1) in patients with relapsed or resistant aggressive CD20 and CD19 positive B-NHL/CLL/SLL.
Official Title
A Phase I/II Safety, Dose Finding and Feasibility Trial of MB-CART2019.1 in Patients With Relapsed or Resistant B-NHL
Conditions
B-cell Non Hodgkin Lymphoma
Intervention / Treatment
- Biological: MB-CART2019.1 Dose level 1
- Biological: MB-CART2019.1 Dose level 2
Other Study ID Numbers
- M-2018-331
Start Date (Actual)
2019-02-25
Primary Completion Date (Actual)
2020-12-17
Study Completion Date (Actual)
2024-05-28
Enrollment (Actual)
12
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Miltenyi Biomedicine GmbH |
| Information Provided By: | Miltenyi Biomedicine GmbH |
| Last Update Posted: | 2025-05-28 |
Study Overview
Brief Summary
This is a prospective, multi-center, open phase I/II trial to evaluate feasibility, dosage, safety and toxicity as well as efficacy of ex vivo expanded autologous T cells genetically modified to express anti-CD20 and CD19 immunoreceptor (MBCART2019.1) in patients with relapsed or resistant aggressive CD20 and CD19 positive B-NHL/CLL/SLL.
Official Title
A Phase I/II Safety, Dose Finding and Feasibility Trial of MB-CART2019.1 in Patients With Relapsed or Resistant B-NHL
Conditions
B-cell Non Hodgkin Lymphoma
Intervention / Treatment
- Biological: MB-CART2019.1 Dose level 1
- Biological: MB-CART2019.1 Dose level 2
Other Study ID Numbers
- M-2018-331
Start Date (Actual)
2019-02-25
Primary Completion Date (Actual)
2020-12-17
Study Completion Date (Actual)
2024-05-28
Enrollment (Actual)
12
Study Type
Interventional
Phase
Phase 1