Actively Recruiting
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Led by Juventas Cell Therapy Ltd. · Updated on 2025-02-07
60
Participants Needed
17
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to sign the informed consent form
- Age between 18 and 75 years, any gender
- Diagnosed with CD19-positive Non-Hodgkin's Lymphoma according to WHO 2017 classification, including diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, transformed follicular lymphoma, and high-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- Previously received at least second-line adequate therapy or autologous hematopoietic stem cell transplantation
- Measurable lesions at screening: intranodal lesions >1.5 cm or extranodal lesions >1.0 cm
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow reserve: ANC > 1.0 x 10^9/L, ALC ≥ 0.3 x 10^9/L, Platelets ≥ 50 x 10^9/L
- Proper organ function meeting specified liver, kidney, lung, and coagulation criteria
- Suitable vascular condition for apheresis
- Negative pregnancy test for women with child-bearing potential and agreement to use effective contraception during the study and for one year after treatment
You will not qualify if you...
- Active central nervous system lymphoma or history of CNS disease such as seizures, stroke, dementia, or autoimmune CNS diseases
- Use of certain drugs or therapies within specified timeframes before apheresis, including alemtuzumab, cladribine, anti-CD20 antibodies, venetoclax, idelalisib, lenalidomide, lymphocytotoxic and non-lymphocytotoxic chemotherapy, and recent radiotherapy
- Chemotherapy within 2 weeks prior to CNCT19 infusion except specified pretreatment or CNS prophylaxis
- Recent discontinuation of systemic hormones unless physiological doses
- Prior CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation
- Active or uncontrolled systemic autoimmune disease under treatment
- Positive tests for hepatitis B, hepatitis C, syphilis, EBV-DNA, or CMV-DNA above detection limits
- Major surgery within 4 weeks before screening
- Active malignancy other than lymphoma or history of malignancy not cured for at least 2 years
- Significant heart conditions including low ejection fraction, severe heart failure, uncontrolled hypertension, recent myocardial infarction, or other heart diseases unsuitable for enrollment
- Lymphoma involving the atrium or ventricle
- Clinical emergencies needing treatment due to lymphoma obstruction
- Active bleeding or recent deep vein thrombosis or pulmonary embolism
- Known hypersensitivity to any study drug ingredients
- Live vaccine within 6 weeks before screening
- Active infection at screening
- Life expectancy less than 3 months
- Participation in other interventional clinical trials or investigational drug treatments within 3 half-lives before CNCT19 infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Beijing Boren Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
Xinqiao Hospital of TMMU
Chongqing, Chongqing Municipality, China
Actively Recruiting
6
Guangdong Provincial Peoples' Hospital
Guangzhou, Guangdong, China
Actively Recruiting
7
SunYat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
9
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
10
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Actively Recruiting
11
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
12
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
13
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Actively Recruiting
14
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
15
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
16
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
17
The First Affiliated Hospital, Zhejiang University school of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yan Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here