Trials / Suspended
SuspendedNCT05138458
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL
A Phase 1/2, Open-Label, First-in-human, Multiple Ascending Dose Multicenter Study of MT-101 in Subjects With CD5+ Relapsed/Refractory T Cell Lymphoma
- Status
- Suspended
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Myeloid Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1/2 study to test the safety, tolerability, and efficacy of the investigational agent MT-101 in patients with T cell Lymphoma. MT-101 is made with myeloid cells collected from the patient's blood. The myeloid cells are modified and later infused back into their veins. The modified myeloid cells recognize the tumor cells and are designed to target and kill them.
Detailed description
The research study is divided into two parts. The first part will be to determine the safety and tolerability of the study drug product. During this part of the study, there will be 4 groups of study patients. The first group of patients will receive a low dose of cells, the second group will receive the low dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood, the third group will receive a higher dose of cells, and the fourth group will receive the higher dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood. In the second part of the study, cells with or without chemotherapy will be administered based on results of Part 1 and the safety, tolerability, and efficacy of MT-101 will be assessed. All patient groups will receive 6 doses of drug product over 3 weeks.
Conditions
- Lymphoma, T-Cell, Peripheral
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
- Adoptive Cellular Immunotherapy
- Cell Therapy
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MT-101 | CD5 ATAK cells |
| OTHER | MT-101 + Conditioning (Lymphodepleting) Chemotherapy | IV administration of fludarabine and cyclophosphamide |
Timeline
- Start date
- 2021-12-15
- Primary completion
- 2024-11-01
- Completion
- 2025-10-01
- First posted
- 2021-12-01
- Last updated
- 2023-11-13
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05138458. Inclusion in this directory is not an endorsement.