Study of Efficacy of BZ019 in Large B-cell Lymphoma

NCT05472610 | Unknown Phase 2

• 1 other identifier: BZ019R-A-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm,open-label, non-randomized phase 2 study to determine the efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma subjects.

Conditions

Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Clinical response will be assessed by RECIST 1.1.

  Month 3

Secondary Outcomes (3)

• Pharmacokinetics (PK)

  Month 12

• Pharmacodynamics (PD)

  Month 12

• Quality of life（QOL）

  Month 12

Study Arms (1)

BZ019

EXPERIMENTAL

The subjects are enrolled into single-dose(1～5x10\^6/kg) of BZ019 ( non viral vector CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Injection).

Biological: BZ019

Interventions

BZ019 BIOLOGICAL

A treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 administered intravenously (IV).

BZ019

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）Written informed consent must be obtained prior to any screening procedures;
• ）75 ≥Age ≥ 18 years subjects；
• ）Subjects who meet the following diagnostic and therapeutic requirements when screening: A）The diagnosis of B Cell NHL was consistent with WHO classification in 2017；
• B） Subjects must be accepted adequate treatment before and have received at least 2 lines of treatment or relapse or progress after autologous hematopoietic stem cell transplantation, and the treatment history at least include:
• a）Treatment by CD20 monoclonal antibody (Rituximab) except for CD20 negative; b) A chemotherapy regimen containing anthracyclines.
• C）With Relapsed or refractory large B-cell lymphoma when screening:
• a) The definition of relapsing is as follows：PD occurs at least after remission (including PR or CR) with standard therapy (including Rituximab) b) The definition of refractory is as follows: i) No response to the last treatment, including:The best response to the latest treatment is PD or SD; ii)Disease progression after ASCT or recurrence within ≤ 12 months (recurrence must be confirmed by biopsy), or if receiving remedial treatment after ASCT, the subject must have no reaction or recurrence after the last treatment.
• D) CD19+ which was detected by immunocytochemistry or flow cytometric ;
• )According to the preliminary evaluation, staging and response evaluation recommendations for Hodgkin and non Hodgkin's lymphoma (2014 Edition), at least one measurable lesion was found in the screening period：the length diameter of the intranodal lesion was greater than 1.5cm,the diameter of the external lesion was greater than 1.0cm;
• \) Life expectancy ≥12 weeks;
• )Baseline Eastern Cooperative Oncology Group (ECOG) score is 0 or 2 Baseline Eastern Cooperative Oncology Group (ECOG) score is 0 or 2 ;
• )Adequate organ function:
• A)Renal function defined as:
• a）A serum creatinine of ≤1.5 x ULN or Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m\^2;
• B）Liver function defined as:

You may not qualify if:

• Patients who have previously received any anti-CD45, anti-CD19 or anti-CD3 therapy;
• Patients who have previously received any adoptive T cell therapy or gene therapy products, including CAR-T therapy;
• Active Central Nervous System (CNS) involvement by malignancy or secondary CNS involvement
• History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or self-immune disease with CNS involvement.
• Prior allogeneic HSCT.
• Patients with positive hepatitis B (HBsAg and / or HBcAb positive, except for those with positive surface antibody alone) or hepatitis C serological markers;
• HIV positive or Treponema pallidum positive patients.
• Patients with uncontrollable active or life-threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours before infusion);
• Patients with unstable angina and / or myocardial infarction within 6 months before screening, or patients with serious or uncontrollable other diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases) during screening;
• Previous or concurrent malignancy with the following exceptions:
• Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
• In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study
• A primary malignancy which has been completely resected and in complete remission for ≥ 5 years
• Pregnant or nursing (lactating) women.
• Patients with uncontrolled arrhythmia.

Sponsors & Collaborators

• Shanghai Mengchao Cancer Hospital: lead
• Shanghai Cell Therapy Group Co.,Ltd: collaborator

Study Sites (1)

Shanghai Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, 201805, China

RECRUITING

Related Publications (1)

• Zhang Y, Lin Z, Zhang F, Chen X, Yang Y, Fu X, Li Z, Sun Y, Qian Q. Rapid response in relapsed follicular lymphoma with massive chylous ascites to anti-CD19 CAR T therapy using Piggy Bac: A case report. Front Immunol. 2022 Dec 1;13:1007210. doi: 10.3389/fimmu.2022.1007210. eCollection 2022.

  PMID: 36532014 DERIVED

Central Study Contacts

Zhang Yan, Ph. D

CONTACT

021-67091122; 1r1-7v5o4ef29a@dingtalk.com

Liang Lijuan, Bachelor

CONTACT

021-67091022; lianglijuan3710@dingtalk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: June 4, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

CN (1)