Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
1 other identifier
interventional
60
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2020
Longer than P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedFebruary 7, 2025
February 1, 2025
3.4 years
October 8, 2020
February 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Partial Remission (PR)
Efficacy of CNCT19 as measured by ORR at the 3 months after CNCT19 Cell Injection infusion, which includes CR and PR.
At 3 months after infusion
Secondary Outcomes (9)
CR rate at 3 months after CNCT19 infusion
3 months
ORR（CR+PR）/CR
28 days
ORR（CR+PR）/CR
6 months
Progression-free survival (PFS)
24 months
Disease-free survival (DFS)
24 months
- +4 more secondary outcomes
Study Arms (1)
Single dose of CNCT19
EXPERIMENTALA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.
Interventions
Dose: 2.00 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Eligibility Criteria
You may qualify if:
- Patients who are willing to sign the informed consent form;
- Aged 18-75 years, male or female;
- At screening, subjects complying with the following diagnostic and treatment requirements:
- 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.
- 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
- Received at least one chemotherapy regimen containing anthracycline;
- Definition of line: Stable disease (SD) after receiving a first-line adequate therapy or progressive disease (PD), and SD after a second-line therapy for at least 2 cycles or PD .
- In relapsed or refractory status at screening:
- Definition of relapse: Remission (including partial remission (PR) or complete remission (CR)) after treatment with at least the standard therapy regimen (it must contain Ribuximab), and then PD;
- Definition of refractoriness:
- +11 more criteria
You may not qualify if:
- 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).
- 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.
- 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;
- Non-lymphocytotoxic chemotherapy within 7 d prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
- Radiotherapy within 6 weeks prior to apheresis, including big bone marrow area (e.g., sternum or pelvis) - progressive disease at radiotherapy site, or PET positive lesion at other non-radiotherapy site is eligible; if there is existing PET positive lesion in other non-radiotherapy sites, then it is allowable to conduct radiotherapy at a single lesion within 2 weeks prior to apheresis.
- Patients receiving chemotherapy within 2 weeks prior to CNCT19 Cell injection infusion, excluding the following conditions:
- Pretreatment chemotherapy as specified by the protocol;
- CNS lymphoma prophylaxis by intrathecal injection (it must be stopped within 1 week prior to infusion of CNCT19 Cell Injection).
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 200025, 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, 300020, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University school of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dehui Zou, Dr.
Institute of Hematology & Blood Diseases Hospital, China
- PRINCIPAL INVESTIGATOR
Weili Zhao, Dr.
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2020
First Posted
October 14, 2020
Study Start
October 26, 2020
Primary Completion
March 30, 2024
Study Completion
September 30, 2025
Last Updated
February 7, 2025
Record last verified: 2025-02