Possibia

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.

locations

Contact Information

Overall Contact

Sandeep Kaur

ClinOps@cullinanoncology.com

+1 617 410 4650

Data sourced from ClinicalTrials.gov