A Phase 1 Study of AUTX-703 in Participants with Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol AUTX-703-001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 69

Countries 1

Sites 2

Relapsed/refractory Acute Myeloid Leukemia or relapsed/refractory myelodysplastic syndromes

Key facts

Sponsor: Auron Therapeutics Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2026-02-04
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: Yes

External identifiers

EU CT number: 2025-521394-13-00
ClinicalTrials.gov: NCT06846606

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Relapsed/refractory Acute Myeloid Leukemia or relapsed/refractory myelodysplastic syndromes

Version	Level	Code	Term	System organ class
27.0	PT	10028533	Myelodysplastic syndrome	100000004864
21.1	PT	10000880	Acute myeloid leukaemia	100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Auron Therapeutics Inc.

Sponsor organisation: Auron Therapeutics Inc.
Address: 55 Chapel Street Suite 102
City: Newton
Postcode: 02458-1060
Country: United States

Scientific contact point

Organisation: Auron Therapeutics Inc.
Contact name: VP, Clinical Development

Public contact point

Organisation: Auron Therapeutics Inc.
Contact name: VP, Clinical Development

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruitment pending	10	2
Rest of world United States	—	59	—

Investigational sites

France

2 sites · Authorised, recruitment pending

Oncopole Claudius Regaud

N/A, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9

Institut Gustave Roussy

N/A, 114 Rue Edouard Vaillant, 94800, Villejuif

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-10-23	France	Acceptable 2026-02-04	2026-02-04