A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prizloncabtagene autoleucel.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Large B-Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1b/2 Study of a Anti-CD19/CD20 Bispecific CAR-T Therapy (C-CAR039/Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma
Overview
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.
Interventions
- Biological Prizloncabtagene autoleucel
Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens
Primary outcome measures
- Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 90 days after C-CAR039 infusion]
- Phase 1b: Recommended Phase 2 Dose (R2PD) [Time frame: Up to 3 months after C-CAR039 infusion]
- Phase 2: Overall Response Rate (ORR) at 3 months [Time frame: Up to 3 months after C-CAR039 infusion]
Secondary outcome measures (12)
- Phase 1b: Incidence and Severity of Adverse Events (AEs) [Time frame: Up to 2 years after C-CAR039 infusion]
- Phase 1b: ORR at 3 months [Time frame: Up to 3 months after C-CAR039 infusion]
- Phase 2: Incidence and Severity of Adverse Events (AEs) [Time frame: Up to 2 years after C-CAR039 infusion]
- ORR [Time frame: Up to 2 years after C-CAR039 infusion]
- ORR at 6 months [Time frame: Up to 6 months after C-CAR039 infusion]
- Duration of response (DOR) [Time frame: Up to 2 years after C-CAR039 infusion]
- Time to response (TTR) [Time frame: Up to 2 years after C-CAR039 infusion]
- Progression-free survival (PFS) [Time frame: Up to 2 years after C-CAR039 infusion]
- Overall survival (OS) [Time frame: Up to 2 years after C-CAR039 infusion]
- Maximal plasma concentration (Cmax) [Time frame: Up to 2 years after C-CAR039 infusion]
- Time to reach the maximal plasma concentration (Tmax) [Time frame: Up to 2 years after C-CAR039 infusion]
- Area under the curve within 28 days (AUC0-28d) [Time frame: Up to 28 days after C-CAR039 infusion]
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:
- Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
- Primary mediastinal large B-cell lymphoma (PMBCL)
- Transformed follicular lymphoma (tFL)
- High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH)
- High-grade B-cell lymphoma, NOS (HGBL, NOS)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 15 centers
- Beijing Cancer Hospital — Beijing
- Beijing GoBroad Hospital — Beijing
- Peking University Third Hospital — Beijing
- Chongqing University Cancer Hospital — Chongqing
- Guangdong Provincial People's Hospital — Guangzhou
- Zhujiang Hospital of Southern Medical University — Guangzhou
- The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
- Cancer Hospital of Shandong First Medical University — Jinan
- … and 7 more centers
Identifiers
NCT: NCT05800977 · 0702-032