Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310811
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-04
Brief Title:
Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Safety Efficacy and Pharmacokinetics Study of Anti-CD19 CAR-T Cell Therapy in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Status:
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 an open Phase I investigator-initiated study IIT to evaluate the safety tolerability pharmacokinetics pharmacodynamics and efficacy of RD06-04 in patients with moderate or severe active SLE
This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels DL with 3 to 6 patients enrolled in each dose level After safety conclusions are reached in each group the investigator can select the corresponding dose group to expand cases based on treatment response but the total number of cases will not exceed 12
This study will enroll patients in a 33 design with two DLS 1105 CART cells kg for DL1 and 5105 CART cells kg for DL2
Dose increment Refer to the 33 dose increment principle Three subjects are expected to be enrolled in each dose group
1 Dose increment should start from the minimum dose and it is not possible to conduct an incremental study of 2 or more dose groups at the same time
2 If 1 case of DLT occurs in each dose group the dose level will be extended to 6 subjects If 6 subjects at this dose level 2 subjects develop DLT the dose level exceeds the MTD The previous lower dose level will be extended to 6 subjects and if 6 subjects have already been enrolled in the previous lower dose level and only 1 of these 6 subjects develop DLT this lower dose level will be considered MTD
3 If DLT occurred in 2 subjects in the highest dose group the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation
4 If the dose increase to the highest dose group still does not reach DLT researchers can explore the safety and efficacy of higher doses according to specific circumstances
Case expansion
After the completion of DLT evaluation in all dose groups the investigators could select the corresponding dose group of extended cases according to the treatment response but the total number of cases should not exceed 12 extended cases were not evaluated by DLT
This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels DL with 3 to 6 patients enrolled in each dose level After safety conclusions are reached in each group the investigator can select the corresponding dose group to expand cases based on treatment response but the total number of cases will not exceed 12
This study will enroll patients in a 33 design with two DLS 1105 CART cells kg for DL1 and 5105 CART cells kg for DL2
Dose increment Refer to the 33 dose increment principle Three subjects are expected to be enrolled in each dose group
1 Dose increment should start from the minimum dose and it is not possible to conduct an incremental study of 2 or more dose groups at the same time
2 If 1 case of DLT occurs in each dose group the dose level will be extended to 6 subjects If 6 subjects at this dose level 2 subjects develop DLT the dose level exceeds the MTD The previous lower dose level will be extended to 6 subjects and if 6 subjects have already been enrolled in the previous lower dose level and only 1 of these 6 subjects develop DLT this lower dose level will be considered MTD
3 If DLT occurred in 2 subjects in the highest dose group the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation
4 If the dose increase to the highest dose group still does not reach DLT researchers can explore the safety and efficacy of higher doses according to specific circumstances
Case expansion
After the completion of DLT evaluation in all dose groups the investigators could select the corresponding dose group of extended cases according to the treatment response but the total number of cases should not exceed 12 extended cases were not evaluated by DLT
Detailed Description:
None
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