Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05944978
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2023-07-06
Brief Title:
A Study of GNC-035 in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological Malignancies
Sponsor:
Sichuan Baili Pharmaceutical Co Ltd
Organization:
Sichuan Baili Pharmaceutical Co Ltd
Study Overview
Official Title:
Phase IbII Clinical Study of GNC-035 Tetra-specific Antibody Injection in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological Malignancies
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open-label multicenter phase IbII clinical trial was conducted to evaluate the safety tolerability pharmacokineticspharmacodynamics and antitumor activity of GNC-035 quad-specific antibody injection in patients with relapsed or refractory chronic lymphocytic leukemia and other hematological malignancies
Detailed Description:
Phase Ib To observe the safety and tolerability of GNC-035 in patients with hematologic malignancies such as relapsedrefractory chronic lymphocytic leukemia and to determine the dose-limiting toxicity DLT and maximum tolerated dose MTD or maximum dose if MTD is not reached MAD of GNC-035 To determine the recommended phase II dose RP2D in hematologic malignancies such as chronic lymphocytic leukemia Phase II To explore the efficacy of GNC-035 in patients with relapsedrefractory chronic lymphocytic leukemia and other hematological malignancies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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