5143996
Last Update Posted: 2023-12-27
Recruiting
All Genders accepted | 18 Years + |
60 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
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)
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
Eligibility
Relevant conditions:
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Sandeep Kaur
ClinOps@cullinanoncology.com
+1 617 410 4650
Data sourced from ClinicalTrials.gov