NCT05800977 A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma
| NCT ID | NCT05800977 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai AbelZeta Ltd. |
| Condition | Relapsed/Refractory Large B-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 112 participants in total. It began in 2023-02-22 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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
Contact & Investigator
Weili Zhao, M.D., PhD
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT05800977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed/Refractory Large B-Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05800977 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05800977 currently recruiting?
Yes, NCT05800977 is actively recruiting participants. Contact the research team at zwl_trial@163.com for enrollment information.
Where is the NCT05800977 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Chongqing, China and 11 additional locations.
Who is sponsoring the NCT05800977 clinical trial?
NCT05800977 is sponsored by Shanghai AbelZeta Ltd.. The principal investigator is Weili Zhao, M.D., PhD at Ruijin Hospital. The trial plans to enroll 112 participants.