Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:21 AM
Study NCT ID:
NCT07315503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study of GC012F in Rheumatoid Arthritis.
Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Organization:
Study Overview
Official Title:
An Open-label Study to Evaluate the Safety and Efficacy of GC012F in Patients With Difficult-to-Treat (D2T) Rheumatoid Arthritis.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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 An Open-label Study to Evaluate the Safety and Efficacy of GC012F in Patients with Difficult-to-Treat (D2T) Rheumatoid Arthritis.
Detailed Description:
This is an open-label, early exploratory clinical study designed to evaluate the safety and efficacy as well as PK and PD profiles of GC012F infusion with or without lymphodepletion in patients with D2T RA.
The study consists of a screening period, apheresis day(s), a baseline period, a period of lymphodepletion conditioning (applicable to subjects in the lymphodepletion cohort \[LD cohort\] and to those in the lymphodepletion-free cohort \[LD-free cohort\] who decide to undergo lymphodepletion and receive a second dose of GC012F infusion), a period of CAR-T cell infusion, and a follow-up period.
Eligible subjects will undergo apheresis and receive infusion after CAR-T product manufacturing is completed. Subjects in the LD cohort will receive lymphodepletion conditioning with fludarabine and cyclophosphamide prior to CAR-T cell infusion. All subjects will be assessed prior to cell infusion, and those meeting infusion criteria will receive CAR-T cell infusion.
The study plans to enroll a total of 9 evaluable subjects; GC012F will be administered at the starting dose of 2 × 105 CAR-T cells/kg. The first 6 subjects will be randomized in a 1:1 ratio after apheresis to the LD cohort (receiving GC012F infusion following lymphodepletion) or the LD-free cohort (directly receiving GC012F infusion without lymphodepletion). After the DLT observation period, i.e., a minimum of 28 days of following GC012F infusion, is completed for all 6 subjects, all available data (including PK, PD, safety, efficacy, and biomarker data) obtained from the treatment period will be reviewed to determine the conditioning regimen and dose for subsequent evaluation. Then, the selected conditioning regimen and dose will be continuously investigated in the subsequent study, with doses being selected based on existing data and adjusted according to emerging data. If GC012F expansion is not detected after infusion in subjects of LD-free cohort, lymphodepletion and a second dose of GC012F infusion may be considered; the proposed dose for the second infusion is 2 × 105 CAR-T cells/kg. The second dose of infusion will not be included in DLT evaluation.
The study consists of a screening period, apheresis day(s), a baseline period, a period of lymphodepletion conditioning (applicable to subjects in the lymphodepletion cohort \[LD cohort\] and to those in the lymphodepletion-free cohort \[LD-free cohort\] who decide to undergo lymphodepletion and receive a second dose of GC012F infusion), a period of CAR-T cell infusion, and a follow-up period.
Eligible subjects will undergo apheresis and receive infusion after CAR-T product manufacturing is completed. Subjects in the LD cohort will receive lymphodepletion conditioning with fludarabine and cyclophosphamide prior to CAR-T cell infusion. All subjects will be assessed prior to cell infusion, and those meeting infusion criteria will receive CAR-T cell infusion.
The study plans to enroll a total of 9 evaluable subjects; GC012F will be administered at the starting dose of 2 × 105 CAR-T cells/kg. The first 6 subjects will be randomized in a 1:1 ratio after apheresis to the LD cohort (receiving GC012F infusion following lymphodepletion) or the LD-free cohort (directly receiving GC012F infusion without lymphodepletion). After the DLT observation period, i.e., a minimum of 28 days of following GC012F infusion, is completed for all 6 subjects, all available data (including PK, PD, safety, efficacy, and biomarker data) obtained from the treatment period will be reviewed to determine the conditioning regimen and dose for subsequent evaluation. Then, the selected conditioning regimen and dose will be continuously investigated in the subsequent study, with doses being selected based on existing data and adjusted according to emerging data. If GC012F expansion is not detected after infusion in subjects of LD-free cohort, lymphodepletion and a second dose of GC012F infusion may be considered; the proposed dose for the second infusion is 2 × 105 CAR-T cells/kg. The second dose of infusion will not be included in DLT evaluation.
Study Oversight
Has Oversight DMC:
True
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?: