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Temporary operational pause; no safety concerns.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 and Cohort 3 | Experimental | MT-101 |
|
| Cohort 2 and Cohort 4 | Experimental | MT-101 preceded by conditioning (lymphodepleting) chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-101 | Biological | CD5 ATAK cells |
| |
| MT-101 + Conditioning (Lymphodepleting) Chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of MT-101 | Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MT-101 cell kinetics in blood | The quantity of MT-101 RNA in the blood. | 4 weeks |
| The objective response rate | The ORR is defined as the number (%) of subjects achieving a best overall response of complete response (CR) or partial response (PR) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | DOR is the time interval between the date of first assessment of PR or CR to the date of the follow-on first documentation of progressive disease or death, whichever occurs earlier. | 48 weeks |
| Progression free survival (PFS) |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Gerber, MD, MPH | Myeloid Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States | ||
| Colorado Blood Cancer Institute |
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Multi-ascending dose escalation
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| Other |
IV administration of fludarabine and cyclophosphamide |
|
| 24 weeks |
PFS is defined as the time from the date of the first administration of MT-101 to the date of first documentation of progressive disease or death, whichever occurs earlier.
| 48 weeks |
| Overall survival (OS) | OS is defined as the time from date of the first administration of MT-101 to the date of death. | 48 weeks |
| Denver |
| Colorado |
| 80218 |
| United States |
| Dana-Farber/Mass General Brigham Cancer Care | Boston | Massachusetts | 02215 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Virginia Comprehensive Cancer Center | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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