CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Active:	Yes
Cancer Type:	Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT05143996
Trial Phases:	Phase I	Protocol IDs:	CLN-049-001 (primary) NCI-2021-13598 2020-005195-35
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Cullinan Therapeutics Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05143996

Summary

CLN-049-001 is a Phase 1, open-label, multicenter, first-in-human trial of CLN-049 in
patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic
Syndrome (MDS)

Objectives

This trial is divided into 3 parts:

Part A - Single Ascending Dose (SAD) - Patients will receive a single dose of CLN-049 via
IV administration and be followed for safety for 28 days

Part B - Multiple Ascending Dose (MAD) - Patients will received CLN-049 every 7 days
(q7d) after an initial Lead-In Dose via IV administration and be followed for safety for
28 days and will then enter long-term follow-up for up to 2 years

Part C - Multiple Ascending Dose (MAD) - Patients will receive CLN-049 q7d via SC
injection and be followed for safety for 28 days and will then enter long-term follow-up
for up to 2 years

The SC injection cohorts will be initiated first, followed by IV administration cohorts

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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