Trial Title:
A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients with Relapsed/Refractory Large B-Cell Lymphoma
NCT ID:
NCT05800977
Condition:
Relapsed/Refractory Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Prizloncabtagene autoleucel
Description:
Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell
(CAR-T) targeting both CD19 and CD20 antigens
Arm group label:
Prizloncabtagene Autoleucel
Other name:
C-CAR039
Summary:
This is a multicenter, single arm, open-label study. The purpose of the study is to
evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the
recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel
(Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).
Detailed description:
The purpose of the study is to evaluate the safety and efficacy of Prizlon-cel. It
includes two phases, Phase 1b and Phase 2. In Phase 1b study, RP2D will be determined.
The selected dose will be further evaluated in the Phase 2 study. The study includes the
following sequential procedures: Screening, Apheresis and CAR-T manufacturing, Baseline,
Lymphodepletion, CAR-T infusion, DLT period (Phase 1b) and Follow-up Visit. Subjects will
be followed for at least 2 years after Prizlon-cel infusion, with up to 15 years
long-term follow-up on a separate study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥ 18 years of age
- Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma,
including the following neoplasms as defined by the 2016 WHO classification of
lymphoid neoplasms:
1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
2. Primary mediastinal large B-cell lymphoma (PMBCL)
3. Transformed follicular lymphoma (tFL)
4. High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
(HGBL-DH/TH)
5. High-grade B-cell lymphoma, NOS (HGBL, NOS)
6. Follicular lymphoma grade 3B (FL3B)
- Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after
autologous stem cell transplantation (ASCT)
- At least one measurable lesion per the Lugano 2014 Classification
- Adequate organ and marrow function
Exclusion Criteria:
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT
within 12 weeks prior to apheresis
- Suspected or confirmed central nervous system involvement
- Stroke or convulsion history within 6 months of signing informed consent form (ICF)
- Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants
treatment
- Uncontrolled active infection
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb)
with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis
C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human
immunodeficiency virus (HIV) antibody; positive syphilis test
- Severe heart, liver, renal or metabolism disease
- Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
- Prior CAR-T therapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Completed
Facility:
Name:
Beijing GoBroad Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Kai Hu, M.D.,PhD
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Jing, M.D.,PhD
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Liu, M.D.,PhD
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenyu Li, M.D.,PhD
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuhua Li, M.D.,PhD
Facility:
Name:
The First Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Jin, M.D.,PhD
Facility:
Name:
Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Zengjun Li, M.D.,PhD
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Wuping Li, M.D.,PhD
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Fan, M.D.,PhD
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili Zhao, M.D., PhD
Facility:
Name:
Chinese Academy of Medical Sciences Hematology Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Lugui Qiu, M.D., PhD
Contact backup:
Last name:
Dehui Zou, M.D., PhD
Facility:
Name:
Tianjin Medical University Cancer Institute& Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Lanfang Li, M.D.,PhD
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Keshu Zhou, M.D.,PhD
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingzhi Zhang, M.D.,PhD
Start date:
February 22, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Shanghai AbelZeta Ltd.
Agency class:
Industry
Source:
Shanghai AbelZeta Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05800977
