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Spots Global Cancer Trial Database for Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma

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Trial Identification

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

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

Study ID: NCT05979792

Interventions

CAR-T Therapy

Study Description

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.

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The First Affiliated Hospital of USTC, Hefei, Anhui, China

The First Affliliated Hospital of Xiamen University, Xiamen, Fujian, China

Henan Cancer Hospital, Zhengzhou, Henan, China

The First Affliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

The Affliliated Hospital of Northwest University, Xi'an, Shanxi, China

West China Hospital Sichuan University, Chengdu, Sichuan, China

The 920th Hospital of the Joint Service Support Force of the People's Liberation Army, Kunming, Yunan, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, , China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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