A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai AbelZeta Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age
Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
Primary mediastinal large B-cell lymphoma (PMBCL)
Transformed follicular lymphoma (tFL)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Prizloncabtagene autoleucel
Biological/VaccinePrizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens
Treatment groups
112 Participants
are divided into 1 treatment groupGroup A: Prizloncabtagene AutoleucelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Incidence and severity of TEAEs , including dose limiting toxicities (DLTs)
Time frame
Up to 90 days after C-CAR039 infusion2
Phase 1b: Recommended Phase 2 Dose (R2PD)
Based on DLTs rates and overall safety profile
Time frame
Up to 3 months after C-CAR039 infusion3
Phase 2: Overall Response Rate (ORR) at 3 months
Best response rate at 3 months after C-CAR039 infusion, including partial response (PR) and complete response (CR)
Time frame
Up to 3 months after C-CAR039 infusionSecondary outcomes
1
Phase 1b: Incidence and Severity of Adverse Events (AEs)
Incidence and severity of AEs
Time frame
Up to 2 years after C-CAR039 infusion2
Phase 1b: ORR at 3 months
Best response rate at 3 months after C-CAR039 infusion, including PR and CR
Time frame
Up to 3 months after C-CAR039 infusion3
Phase 2: Incidence and Severity of Adverse Events (AEs)
Incidence and severity of any AEs
Time frame
Up to 2 years after C-CAR039 infusion4
ORR
Best response, including PR and CR
Time frame
Up to 2 years after C-CAR039 infusionSponsors and contacts
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Source ClinicalTrials.gov