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Spots Global Cancer Trial Database for A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

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Trial Identification

Brief Title: A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

Official Title: A Prospective, Multicenter, Single-Arm Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

Study ID: NCT03191773

Study Description

Brief Summary: Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.

Detailed Description: Despite progress has been made to date in the treatment of patients with B cell malignancies, including leukemia and lymphoma, many patients with relapsed or refractory diseases do not respond to the standard treatments. It has been shown that anti-CD19 CAR-transduced T cells may be an effective approach to treat the relapsed or refractory diseases. The procedure involves collecting PBMCs from the patients and modifying the T cells to attack the malignant B cells. In this trial, autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) containing the signaling domains of CD28 or 4-1BB and CD3-zeta will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be pretreated with a lymphodepleting preconditioning regimen before the infusion of anti-CD19 CAR T cells, and will be monitored for safety, adverse events, persistence of anti-CD19 CAR-transduced T cells and the treatment efficacy.

Keywords

Eligibility

Minimum Age: 14 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Hematology, Dongguan People's Hospital, Dongguan, Guangdong, China

Department of Hematology, the First People's Hospital of Foshan, Foshan, Guangdong, China

Department of Hematology, Guangzhou First People's Hospital, Guangzhou, Guangdong, China

Department of Hematology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, China

Department of Hematology,the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Contact Details

Name: Ying Feng, MD

Affiliation: Second Affiliated Hospital of Guangzhou Medical University

Role: STUDY_DIRECTOR

Name: Mingjun Wang, MD

Affiliation: Shenzhen Institute for Innovation and Translational Medicine

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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