Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06206902
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
F01 in the Treatment of Relapsed/Refractory Non-hodgkin's Lymphoma
Sponsor:
Shanghai Simnova Biotechnology Co.,Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Open Phase I Study to Evaluate the Safety and Pharmacokinetic Profile of F01 in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-12
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 multicenter, open, Phase I clinical study to evaluate the safety and tolerability of F01 in subjects with relapsed/refractory non-Hodgkin lymphoma, and to determine MTD and/or RD.
Detailed Description:
Approximately 55 participants with relapsed and/or refractory large B-cell lymphoma and follicular lymphoma stage 3b are planned to enroll. This study is divided into two stages: dose escalation and dose extension. In the phase of dose escalation, a single dose escalation study will be carried out first, and then multiple dose escalation studies will be carried out. In the dose expansion phase, up to 3 subjects who had previously received CD19-targeted CAR T cell therapy may enroll.
After the completion of the single dose escalation study, SRC will determine the MTD and/or RD of the single dose escalation phase based on the safety, pharmacokinetic profile (if applicable), immunogenicity, efficacy, and other data available at the time for each dose group. SRC will also determine whether the study will continue with multiple dose escalation studies or a single dose is sufficient to meet therapeutic needs. Multiple dose escalation can be skipped to provide recommendations for dose expansion phase studies based directly on single dose MTD and/or RD doses. After fully evaluating all opinions and data, the sponsor may choose to: 1) Multiple dose escalation studies are not conducted, and the MTD and/or RD doses with a single dose increase are directly entered into the dose expansion phase. In this case, enrolled subjects are continued to receive a single dose during the dose expansion phase to further confirm the safety and efficacy of subjects under RD dose; 2) After the single dose increment, enter the multi-dose increment study, and enter the dose extension phase after confirming the MTD and/or RD doses of multiple doses.
After the completion of the single dose escalation study, SRC will determine the MTD and/or RD of the single dose escalation phase based on the safety, pharmacokinetic profile (if applicable), immunogenicity, efficacy, and other data available at the time for each dose group. SRC will also determine whether the study will continue with multiple dose escalation studies or a single dose is sufficient to meet therapeutic needs. Multiple dose escalation can be skipped to provide recommendations for dose expansion phase studies based directly on single dose MTD and/or RD doses. After fully evaluating all opinions and data, the sponsor may choose to: 1) Multiple dose escalation studies are not conducted, and the MTD and/or RD doses with a single dose increase are directly entered into the dose expansion phase. In this case, enrolled subjects are continued to receive a single dose during the dose expansion phase to further confirm the safety and efficacy of subjects under RD dose; 2) After the single dose increment, enter the multi-dose increment study, and enter the dose extension phase after confirming the MTD and/or RD doses of multiple doses.
Study Oversight
Has Oversight DMC:
False
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?: