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

RECRUITINGPHASE2

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

NCT04586478•Juventas Cell Therapy Ltd.

View on ClinicalTrials.gov

Summary

Detailed Description

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. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period (2 years at most).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients who are willing to sign the informed consent form;
•2. Aged 18-75 years, male or female;
•3. At screening, subjects complying with the following diagnostic and treatment requirements:
•1. Complying with CD19-positive NHL according to the WHO classification 2017, which are provided specifically as follows:
•* Diffuse large B cell lymphoma (DLBCL), not otherwise specified (NOS);
•* Primary mediastinal large B cell lymphoma (PMBCL);
•* Transformed follicular lymphoma
•* High grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high grade B cell lymphoma - not otherwise specified.
•2. Previously received≥2nd-line adequate therapy or autologous hematopoietic stem cell transplantation (ASCT), including:
•* Received at least Rituximab or other CD20 targeted drugs containing (except CD20 negative tumors) chemotherapy and
+16 more criteria

Exclusion Criteria

•1. Patients with active central nervous system (CNS) lymphoma (a patient with CNS disease symptoms must receive lumbar puncture and MRI/CT to exclude CNS lymphoma).
•2. Patients with existing central nervous system disease or with a history of central nervous system disease, e.g., epileptic seizure, cerebral ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellum disease, organic brain syndrome, mental disease, or any autoimmune disease involved with central nervous system.
•3. Patients receiving any of the following drugs or therapies within the specified period prior to apheresis:
•* Alemtuzumab within 6 months prior to apheresis;
•* Cladribine within 3 months prior to apheresis;
•* Anti-CD20 monoclonal antibody within 7 d prior to apheresis;
•* Venetoclax (BCL-2 inhibitor) within 4 d prior to apheresis;
•* Idelalisib (PI3Kδ kinase inhibitor) within 2 d prior to apheresis;
•* Lenalidomide within 1 d prior to apheresis;
•* Lymphocytotoxic chemotherapy within 2 weeks prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
+21 more criteria

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

Key Dates

Start Date

October 26, 2020

Primary Completion Date

March 30, 2024

Completion Date

September 30, 2025

Last Updated

February 7, 2025

Enrollment

ESTIMATED participants

Conditions

Non-Hodgkin's Lymphoma

Interventions

single dose of CNCT19

BIOLOGICAL

Contacts

Yan Zhou

CONTACT

+8615010390127 zhouyan@juventas.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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