Clinical trial · Interventional
A Study of C-CAR039 (Prizloncabtagene Autoleucel) in 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
NCT05800977CI-TRIAL-00099940ELEVATIONrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Large B-Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prizloncabtagene autoleucel | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prizloncabtagene Autoleucel
- description
- Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion.
- interventionNames
- Biological: Prizloncabtagene autoleucel
Primary outcomes (3)
- measure
- Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- Up to 90 days after C-CAR039 infusion
- description
- Incidence and severity of TEAEs , including dose limiting toxicities (DLTs)
- measure
- Phase 1b: Recommended Phase 2 Dose (R2PD)
- timeFrame
- Up to 3 months after C-CAR039 infusion
- description
- Based on DLTs rates and overall safety profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.