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NCT03503968
TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms
Phase 1, PHASE2 trial testing MDG1011 in Safety in 9 participants. Terminated before completion.
28 June 2022
Quick facts
| Lead sponsor | Medigene AG |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 27 March 2018 |
| Primary completion | 28 June 2022 |
| Estimated completion | 15 July 2022 |
| Sites | 9 locations across Germany |
Drugs / interventions tested
- MDG1011 — full drug profile →
- Investigator Choice therapy
Conditions studied
- Safety — all drugs for Safety →
- Tolerability — all drugs for Tolerability →
- Feasibility — all drugs for Feasibility →
- Treatment Efficacy — all drugs for Treatment Efficacy →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
T-Cell Receptor-Based Immunotherapy for Hematologic Malignancies.
Biernacki MA, Brault M, Bleakley M. · · 2019 · cited 34× · PMID 31135525 · DOI 10.1097/ppo.0000000000000378
Verify or expand the search:
- PubMed search for NCT03503968
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Medigene AG trials
Trials by the same sponsor.
- NCT06748872 — EPITOME-1015-I: a Study to Investigate the Safety and Tolerability of MDG1015 in Patients with Epithelial Ovarian Cancer · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03503968 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medigene AG
- Last refreshed: 15 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03503968.
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