Evaluating Prizloncabtagene Autoleucel for patients with relapsed/refractory large B-cell lymphoma
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
This study is testing a new treatment called Prizloncabtagene Autoleucel to see if it can help people with relapsed or hard-to-treat large B-cell lymphoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai AbelZeta Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 15 sites (Beijing and 14 other locations) |
| Trial ID | NCT05800977 on ClinicalTrials.gov |
What this trial studies
This multicenter, single-arm, open-label study aims to assess the safety and efficacy of Prizloncabtagene Autoleucel (Prizlon-cel) in patients with relapsed or refractory large B-cell lymphoma. The study consists of two phases: Phase 1b focuses on determining the recommended Phase 2 dose (RP2D), while Phase 2 evaluates the treatment's efficacy. Participants will undergo a series of procedures including screening, apheresis for CAR-T manufacturing, lymphodepletion, and CAR-T infusion, followed by a minimum of two years of follow-up. Long-term follow-up may extend up to 15 years in a separate study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma who have relapsed or refractory disease after multiple lines of therapy.
Not a fit: Patients who have undergone prior allogeneic hematopoietic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to apheresis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat large B-cell lymphoma.
How similar studies have performed: Other studies have shown promising results with CAR-T therapies for similar conditions, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing and 14 other locations
- Beijing Cancer Hospital — Beijing, China (Completed)
- Beijing GoBroad Hospital — Beijing, China (Recruiting)
- Peking University Third Hospital — Beijing, China (Recruiting)
- Chongqing University Cancer Hospital — Chongqing, China (Recruiting)
- Guangdong Provincial People's Hospital — Guangzhou, China (Recruiting)
- Zhujiang Hospital of Southern Medical University — Guangzhou, China (Recruiting)
- The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
- Cancer Hospital of Shandong First Medical University — Jinan, China (Recruiting)
- Jiangxi Cancer Hospital — Nanchang, China (Recruiting)
- Jiangsu Province Hospital — Nanjing, China (Recruiting)
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)
- Chinese Academy of Medical Sciences Hematology Hospital — Tianjin, China (Recruiting)
- Tianjin Medical University Cancer Institute& Hospital — Tianjin, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, China (Recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)
Study contacts
- Principal investigator: Weili Zhao, M.D., PhD — Ruijin Hospital
- Study coordinator: Weili Zhao, M.D., PhD
- Email: zwl_trial@163.com
- Phone: 86-021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.