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ACTIVE NOT RECRUITING
NCT05493800
PHASE2

Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT

Sponsor: MitoImmune Therapeutics

View on ClinicalTrials.gov

Summary

Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).

Official title: A Phase IIa, Multi-center, Dose-finding Study to Evaluate Safety and Efficacy for Prevention of Oral Mucositis and PK of MIT-001 in Patients With Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Auto HSCT

Key Details

Gender

All

Age Range

19 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-02-01

Completion Date

2024-12-30

Last Updated

2024-05-29

Healthy Volunteers

No

Interventions

DRUG

MIT-001

Corresponding dose of MIT-001 IV injection during 0.5\~1hr

DRUG

normal saline

normal saline IV injection

Locations (2)

Seoul ST. Mary's Hospital

Seoul, South Korea

Yeouido ST. Mary's Hospital

Seoul, South Korea