Ignite Creation Date:
2024-05-06 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05143996
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2021-10-26
Brief Title:
CLN-049 in Patients With RelapsedRefractory Acute Myeloid Leukemia AML or Myelodysplastic Syndrome MDS
Sponsor:
Cullinan Therapeutics Inc
Organization:
Cullinan Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Open-label Preliminary Pharmacokinetics PK and Safety Study of CLN-049 An Fms-like Tyrosine Kinase 3 FLT3 x Cluster of Differentiation 3 CD3 Bispecific T Cell Engager in Patients With RelapsedRefractory Acute Myeloid Leukemia AML or Myelodysplastic Syndrome MDS
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CLN-049-001 is a Phase 1 open-label multicenter first-in-human trial of CLN-049 in patients with RelapsedRefractory Acute Myeloid Leukemia AML or Myelodysplastic Syndrome MDS
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005195-35 | EUDRACT_NUMBER | None | None |