Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-27 @ 10:34 AM
Study NCT ID:
NCT05979792
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2023-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma
Sponsor:
Zhao Weili
Organization:
Study Overview
Official Title:
Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
NOT_YET_RECRUITING
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:
Despite the use of monoclonal antibodies, checkpoint inhibitors, and bispecific T cell adapters (BiTE) Immunotherapies such as chimeric antigen receptor (CAR) T cells have completely changed the treatment methods of various cancers.
However, only limited responses were observed in T cell diseases, In CD30 positive PTCL and CTCL patients. The use of BV in and pembroluzimab (Programmed cell death receptor 1) in the treatment of ENKTL.
Although some promising results have been observed for (PD-1) inhibitors, these positive results are limited to specific subtypes of T cell diseases.
CAR T Cell therapy in recurrent/refractory B-cell malignant tumors is very successful, the Food and Drug Administration (FDA) has approved two CAR T Cell therapy for the treatment of this type of disease. However, using this technology to treat T-cell malignancies has always been difficult, mainly due to the lack of tumor specific surface antigens in cancerous T cells.
Therefore, our center plans to conduct a phase I clinical study of CAR-T to explore the possibility of bringing more treatment options and benefits to PTCL patients.
However, only limited responses were observed in T cell diseases, In CD30 positive PTCL and CTCL patients. The use of BV in and pembroluzimab (Programmed cell death receptor 1) in the treatment of ENKTL.
Although some promising results have been observed for (PD-1) inhibitors, these positive results are limited to specific subtypes of T cell diseases.
CAR T Cell therapy in recurrent/refractory B-cell malignant tumors is very successful, the Food and Drug Administration (FDA) has approved two CAR T Cell therapy for the treatment of this type of disease. However, using this technology to treat T-cell malignancies has always been difficult, mainly due to the lack of tumor specific surface antigens in cancerous T cells.
Therefore, our center plans to conduct a phase I clinical study of CAR-T to explore the possibility of bringing more treatment options and benefits to PTCL patients.
Detailed Description:
Patients with recurrent/refractory PTCL were included using a single arm, open label, and single center approach.
Pre treatment plan:
Cyclophosphamide (CTX): 500mg/m2 × 3 days
Fludarabine: 30mg/m2 × 3 days
Note: Researchers can adjust the pre-treatment plan appropriately based on the patient's condition, such as CTX 300mg × Wait for 3 days.
CTX and Flu were infused on the 5th to 3rd day (D-5 to D-3) before administration. RD13-02 can only be injected after 48 hours of pre-treatment.
Pre treatment plan:
Cyclophosphamide (CTX): 500mg/m2 × 3 days
Fludarabine: 30mg/m2 × 3 days
Note: Researchers can adjust the pre-treatment plan appropriately based on the patient's condition, such as CTX 300mg × Wait for 3 days.
CTX and Flu were infused on the 5th to 3rd day (D-5 to D-3) before administration. RD13-02 can only be injected after 48 hours of pre-treatment.
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?: