Myelodysplastic Syndrome (MDS) Clinical Trial
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 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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02626715 -
Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS
|
Phase 2 | |
| Recruiting |
NCT02905552 -
Myelodysplasic Syndromes and Risk Factors for Infection
|
N/A | |
| Completed |
NCT01772953 -
Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT
|
Phase 2 | |
| Suspended |
NCT01211691 -
Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06294275 -
A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00533416 -
Safety of ON 01910.Na in Patients With Myelodysplasia
|
Phase 1 | |
| Active, not recruiting |
NCT04401748 -
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
|
Phase 3 | |
| Recruiting |
NCT04608110 -
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome
|
Phase 1 | |
| Recruiting |
NCT03613532 -
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
|
Phase 1 | |
| Withdrawn |
NCT03486353 -
A Study of FF-10501-01 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome
|
Phase 2 | |
| Terminated |
NCT02259348 -
Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation
|
Phase 2 | |
| Terminated |
NCT01422486 -
Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome
|
Phase 2 | |
| Terminated |
NCT01459159 -
Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome
|
Phase 2 | |
| Terminated |
NCT00542828 -
Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome
|
Phase 2 | |
| Completed |
NCT01685619 -
AML-MDS Novel Prognostic Tests Clinical Study
|
||
| Recruiting |
NCT01861093 -
Safety Study of Cord Blood Units for Stem Cell Transplants
|
Phase 2 | |
| Unknown status |
NCT01983761 -
Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
| Completed |
NCT01338337 -
Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia
|
Phase 2 | |
| Completed |
NCT01221857 -
Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
|
Phase 1/Phase 2 |