RecruitingPhase 2NCT04586478

Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Sponsor

Juventas Cell Therapy Ltd.

Enrollment

60 participants

Start Date

Oct 26, 2020

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin's Lymphoma

Summary

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy called CNCT19 in people with relapsed or refractory (returned or treatment-resistant) B-cell non-Hodgkin's lymphoma. CAR-T therapy takes your own immune cells, modifies them in a lab to attack cancer cells, and infuses them back into your body. **You may be eligible if...** - You are 18–75 years old - You have a CD19-positive B-cell non-Hodgkin's lymphoma (such as DLBCL, PMBCL, transformed follicular lymphoma, or high-grade B-cell lymphoma) - Your cancer has returned or not responded after at least 2 prior lines of treatment, including rituximab-containing chemotherapy and an anthracycline-containing regimen - You are in relapsed or refractory status at the time of the study **You may NOT be eligible if...** - You have active brain involvement by the lymphoma - You have severe organ dysfunction (heart, lung, liver, or kidney) - You are pregnant or breastfeeding - You have active infections including HIV, hepatitis B or C - Your cancer is CD19-negative Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALsingle dose of CNCT19

Dose: 2.00 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Locations(17)

Beijing Boren Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Xinqiao Hospital of TMMU

Chongqing, Chongqing Municipality, China

Guangdong Provincial Peoples' Hospital

Guangzhou, Guangdong, China

SunYat-Sen University Cancer Center

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT04586478

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