NCT05138458: IMAGINE

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

Suspended Phase 1/Phase 2 Last updated 9 November 2023

What this trial tests

Phase 1/Phase 2 trial testing MT-101 in Lymphoma, T-Cell, Peripheral in 40 participants. Suspended.

Timeline

15 December 2021

Primary endpoint
1 November 2024

1 October 2025

Quick facts

Lead sponsor	Myeloid Therapeutics
Phase	Phase 1/Phase 2
Status	Suspended
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	15 December 2021
Primary completion	1 November 2024
Estimated completion	1 October 2025
Sites	6 locations across United States

Drugs / interventions tested

• MT-101 — full drug profile →
• MT-101 + Conditioning (Lymphodepleting) Chemotherapy

Conditions studied

• Lymphoma, T-Cell, Peripheral — all drugs for Lymphoma, T-Cell, Peripheral →
• Lymphoma, T-Cell, Cutaneous — all drugs for Lymphoma, T-Cell, Cutaneous →
• Mycosis Fungoides — all drugs for Mycosis Fungoides →
• Adoptive Cellular Immunotherapy — all drugs for Adoptive Cellular Immunotherapy →

Sponsor

Myeloid Therapeutics — full company profile →

Who can join

18 and older, any sex, with Lymphoma, T-Cell, Peripheral or Lymphoma, T-Cell, Cutaneous. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety and Tolerability of MT-101
  Time frame: 4 weeks
  Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploring treatment options in cancer: Tumor treatment strategies.
   Liu B, Zhou H, Tan L, Siu KTH, et al · · 2024 · cited 536× · PMID 39013849 · DOI 10.1038/s41392-024-01856-7
2. Targeting macrophages in hematological malignancies: recent advances and future directions.
   Li W, Wang F, Guo R, Bian Z, et al · · 2022 · cited 126× · PMID 35978372 · DOI 10.1186/s13045-022-01328-x
3. The CAR macrophage cells, a novel generation of chimeric antigen-based approach against solid tumors.
   Hadiloo K, Taremi S, Heidari M, Esmaeilzadeh A. · · 2023 · cited 81× · PMID 38017494 · DOI 10.1186/s40364-023-00537-x
4. Clinical landscape of macrophage-reprogramming cancer immunotherapies.
   Rannikko JH, Hollmén M. · · 2024 · cited 70× · PMID 38831013 · DOI 10.1038/s41416-024-02715-6
5. Therapeutic challenges in peripheral T-cell lymphoma.
   Luan Y, Li X, Luan Y, Luo J, et al · · 2024 · cited 34× · PMID 38178117 · DOI 10.1186/s12943-023-01904-w
6. Tumor Biology Hides Novel Therapeutic Approaches to Diffuse Large B-Cell Lymphoma: A Narrative Review.
   Masnikosa R, Cvetković Z, Pirić D. · · 2024 · cited 17× · PMID 39518937 · DOI 10.3390/ijms252111384
7. Harnessing myeloid cells in cancer.
   Park SY, Pylaeva E, Bhuria V, Gambardella AR, et al · · 2025 · cited 15× · PMID 40050933 · DOI 10.1186/s12943-025-02249-2
8. Chimeric Antigen Receptor Based Cellular Therapy for Treatment Of T-Cell Malignancies.
   Polgárová K, Otáhal P, Šálek C, Pytlík R. · · 2022 · cited 14× · PMID 35600381 · DOI 10.3389/fonc.2022.876758