Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318884
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-12
Brief Title:
A First-in-human Study of SCTB35 in Patients With RelapseRefractory B-cell Non-Hodgkin Lymphoma
Sponsor:
Sinocelltech Ltd
Organization:
Sinocelltech Ltd
Study Overview
Official Title:
A Phase IaIb Dose-escalation and Dose-expansion Study Evaluating the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of SCTB35 in Patients With CD20 RelapseRefractory B-cell Non-Hodgkin Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
This is a Phase I clinical study designed to evaluate the safety tolerability and pharmacokinetics and preliminary efficacy of SCTB35 monotherapy an bispecific antibody in patients with relapsed andor refractory B-cell non-Hodgkin lymphoma
Detailed Description:
This is the first-in-human study of SCTB35 containing the dose-escalation and dose-expansion parts The escalation cohorts will be enrolled to explore the maximum tolerated dose and recommended phase II dose RP2D A Safety Monitoring Committee SMC will review the accumulated safety data and other available data and make a recommendation to each dose level of SCTB35 in the escalation cohorts The expansion cohorts will be initiated after the RP2D is confirmed and to further compare the preliminary efficacy and safety of SCTB35 at two dose levels that appropriately recommended by SMC
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