A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma

Phase 2RecruitingNCT05800977

Shanghai AbelZeta Ltd.112 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Relapsed/Refractory Large B-Cell Lymphoma

Interventions

Prizloncabtagene autoleucelBIOLOGICAL

Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Beijing Cancer Hospital

Beijing, China

COMPLETED

Beijing GoBroad Hospital

Beijing, China

Outcomes

Primary Outcomes

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 infusion

Phase 1b: Recommended Phase 2 Dose (R2PD)

Based on DLTs rates and overall safety profile

Time frame: Up to 3 months after C-CAR039 infusion

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 infusion

Secondary Outcomes

Phase 1b: Incidence and Severity of Adverse Events (AEs)

Incidence and severity of AEs

Time frame: Up to 2 years after C-CAR039 infusion

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 infusion

Phase 2: Incidence and Severity of Adverse Events (AEs)

Incidence and severity of any AEs

Time frame: Up to 2 years after C-CAR039 infusion

ORR

Best response, including PR and CR

Time frame: Up to 2 years after C-CAR039 infusion

ORR at 6 months

Best response rate at 6 months after C-CAR039 infusion, including PR and CR

Central Contacts

Weili Zhao, M.D., PhD

CONTACT

86-021-64370045 zwl_trial@163.com

Lugui Qiu, M.D., PhD

CONTACT

86-13821266636 Qiulg@ihcams.ac.cn

Data from ClinicalTrials.gov

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