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NCT03503968

TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms

Terminated Phase 1, PHASE2 Last updated 15 February 2023
What this trial tests

Phase 1, PHASE2 trial testing MDG1011 in Safety in 9 participants. Terminated before completion.

Timeline
27 March 2018
Primary endpoint
28 June 2022
15 July 2022

Quick facts

Lead sponsorMedigene AG
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment9
Start date27 March 2018
Primary completion28 June 2022
Estimated completion15 July 2022
Sites9 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Medigene AG — full company profile →

Who can join

18 and older, any sex, with Safety or Tolerability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicentre, non-randomized, open-label, Phase I/II clinical trial of MDG1011, an investigational medicinal product (IMP), consisting of patient-derived autologous T cells, persistently transduced with a Preferentially Expressed Antigen in Melanoma (PRAME)-specific human leukocyte antigen (HLA)-A\*02:01-restricted T cell receptor (TCR).

Publications & conference data

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

  1. Clinical cancer immunotherapy: Current progress and prospects.
    Liu C, Yang M, Zhang D, Chen M, et al · · 2022 · cited 147× · PMID 36304470 · DOI 10.3389/fimmu.2022.961805
  2. T cell receptor therapeutics: immunological targeting of the intracellular cancer proteome.
    Klebanoff CA, Chandran SS, Baker BM, Quezada SA, et al · · 2023 · cited 132× · PMID 37891435 · DOI 10.1038/s41573-023-00809-z
  3. The Emerging World of TCR-T Cell Trials Against Cancer: A Systematic Review.
    Zhang J, Wang L. · · 2019 · cited 115× · PMID 30798772 · DOI 10.1177/1533033819831068
  4. Engineered TCR-T Cell Immunotherapy in Anticancer Precision Medicine: Pros and Cons.
    Zhao Q, Jiang Y, Xiang S, Kaboli PJ, et al · · 2021 · cited 97× · PMID 33859650 · DOI 10.3389/fimmu.2021.658753
  5. Cancer Testis Antigens and Immunotherapy: Where Do We Stand in the Targeting of PRAME?
    Al-Khadairi G, Decock J. · · 2019 · cited 85× · PMID 31311081 · DOI 10.3390/cancers11070984
  6. Chimeric Antigen Receptor (CAR) T Cell Therapy in Acute Myeloid Leukemia (AML).
    Hofmann S, Schubert ML, Wang L, He B, et al · · 2019 · cited 84× · PMID 30736352 · DOI 10.3390/jcm8020200
  7. Recent Advances in Immune-Based Therapies for Acute Myeloid Leukemia.
    Restelli C, Ruella M, Paruzzo L, Tarella C, et al · · 2024 · cited 36× · PMID 38904305 · DOI 10.1158/2643-3230.bcd-23-0202
  8. T-Cell Receptor-Based Immunotherapy for Hematologic Malignancies.
    Biernacki MA, Brault M, Bleakley M. · · 2019 · cited 34× · PMID 31135525 · DOI 10.1097/ppo.0000000000000378

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Other recruiting trials for Safety

Currently open trials in the same condition.

Other Medigene AG trials

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Data sources for this page

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