RecruitingPhase 2NCT04684147

Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase Ⅱ Clinical Trial of CNCT19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia


Sponsor

Juventas Cell Therapy Ltd.

Enrollment

100 participants

Start Date

Dec 24, 2020

Study Type

INTERVENTIONAL

Conditions

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 CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a CAR-T cell therapy called CNCT19 — a treatment where your own immune cells are engineered to attack leukemia cells — in adults with acute lymphoblastic leukemia (ALL) that has come back or stopped responding to standard treatment. **You may be eligible if...** - You are between 18 and 65 years old - You have relapsed or treatment-resistant (refractory) ALL - Your leukemia cells carry a protein called CD19 on their surface - Your cancer came back within 12 months of first remission, or did not respond to at least two rounds of chemotherapy, or returned after a bone marrow transplant **You may NOT be eligible if...** - Your leukemia cells do not express CD19 - You are under 18 or over 65 - You have conditions that prevent you from safely receiving this therapy 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: 0.5 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide


Locations(11)

Beijing Boren Hospital

Beijing, Beijing Municipality, China

Xinqiao Hospital of TMMU

Chongqing, Chongqing Municipality, China

Nanfang Hospital

Guangzhou, Guangdong, China

Yanda hospital, Hebei medical university

Sanhe, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

The affiliated hospital of Xuzhou medical university

Xuzhou, Jiangsu, 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

The First Affiliated Hospital, Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT04684147