NCT04464889

HA-1H TCR T Cell for Relapsed/Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplantation

A Dose-Escalation, Open Label Phase I Study to Assess the Safety, Feasibility and Preliminary Efficacy of HA-1H TCR Modified T Cells, MDG1021, in Patients With Relapsed or Persistent Hematologic Malignancies After Allogeneic HSCT With or Without Unmanipulated DLI

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medigene AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomised, open-label phase I study of an investigational medicinal product (IMP) consisting of a HLA-A\*02:01 restricted HA-1H T cell receptor transduced T cell (MDG1021) immunotherapy for relapsed or persistent hematologic malignancies after allogeneic hematopoietic stem cell transplantation. The aim of the study is to determine the recommended phase II dose of MDG1021.

Detailed description

This phase I is designed to assess the safety and feasibility of a HLA-A\*02:01 restricted, HA-1H T cell receptor (TCR) transduced patient-derived T cell (MDG1021) immunotherapy, with secondary endpoints including preliminary efficacy, in patients with relapsed or persistent hematologic malignancies after allogeneic hematopoietic stem cell transplantation. In the dose-escalation part of the study, at least 9 patients will be treated with MDG1021 at 3 different doses to assess the safety and the maximum tolerated dose using a standard 3+3 cohort design. Thereafter, the selected optimal MDG1021 dose will be assessed for safety and preliminary efficacy in 20 additional patients during the dose-expansion part of the study. Manufacturing feasibility will be determined. MDG1021 will be administered by single intravenous infusion. HA-1H is exclusively expressed on cells of the hematopoietic system. If the patient's blood-cells, and thus lymphoma or leukemic cells, carry the immunogenic version of the HA-1H antigen on their surface and the donor stem cells do not, MDG1021 immunotherapy could eradicate the patient's cancer cells and allow the donor stem cells to repopulate the patient's blood forming system.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoid Leukemia
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Chronic Myeloid Leukemia
• Myelofibrosis
• Multiple Myeloma
• Malignant Lymphoma

Interventions

Type	Name	Description
DRUG	MDG1021 dose 1	3 patients to receive dose1: target dose of 0.3x10\^6 HA-1H TCR transduced T cells/kg BW ±20% in 100 mL
DRUG	MDG1021 dose 2	3 patients to receive dose 2: target dose of 1x10\^6 HA-1H TCR transduced T cells/kg BW ±20% in 100 mL
DRUG	MDG1021 dose 3	3 patients to receive dose 3: target dose of 3x10\^6 HA-1H TCR transduced T cells/kg BW +20% in 100 mL
DRUG	MDG1021 optimal dose	20 patients to receive the selected optimal dose

Timeline

• Start date: 2020-07-02
• Primary completion: 2023-07-01
• Completion: 2025-07-01
• First posted: 2020-07-09
• Last updated: 2021-10-08

Locations

1 site across 1 country: Netherlands