A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)

NCT06446128 | Recruiting Early Phase 1

• 1 other identifier: BZE2204-A-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.

Conditions

Non-Hodgkin Lymphoma, B-cell

Keywords

B cell non-hodgkin lymphoma; CAR-T; CD19; CD22; BCMA

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT)

  Safety

  Day0-Day28

• Maximum tolerated dose (MTD)

  Tolerability

  Day0-Day28

Secondary Outcomes (7)

• Maximum Plasma Concentration(Cmax)

  Day0-Day28，Day0-undetectable for CAR positive T cells

• Maximum Plasma Concentration Time (Tmax)

  Day0-Day28，Day0-undetectable for CAR positive T cells

• Area Under Curve (AUC)

  Day0-Day28，Day0-undetectable for CAR positive T cells

• CAR positive T cells

  Day0-Day28，Day0-undetectable for CAR positive T cells

• Cytokines ( IL(interleukin)-2, IL-4, IL-6, IL-8, IL-10, IL-15, IFN(interferon)-γ, TNF(tumor necrosis factor)-α and MCP( monocyte chemoattractant protein)-1)

  Day0-Day28

Study Arms (1)

CD19/CD20/BCMA CAR T therapy

EXPERIMENTAL

The safety and tolerability of BZE2204 will be assessed in a "1+1+1+3" and "3+3" dose escalation approach in different B-cell non-hodgkin lymphoma

Biological: CD19/CD20/BCMA CAR T cells

Interventions

CD19/CD20/BCMA CAR T cells BIOLOGICAL

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CD19/CD20/BCMA CAR T cells. Cyclophosphamide and fludarabine will be given from day-5 to day-3 before the infusion for lymphodepletion. On day0 subjects will receive one dose treatment with CD19/CD20/BCMA CAR T cells by intravenous (IV) injection

CD19/CD20/BCMA CAR T therapy

Eligibility Criteria

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

You may qualify if:

• Patients who are diagnosed with relapsed/refractory B cell non-Hodgkin lymphoma , especially
• Diffuse Large B Cell Lymphoma, not other specified (DLBCL,NOS),
• Primary Mediastinal Large B Cell Lymphoma (PMBCL)
• Transformation Follicular Lymphoma (TFL)
• High grade B-cell lymphoma(HGBCL)
• High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) /BCL6 (B-cell lymphoma6) rearrangement
• Refractory diseases are defined as one of the following
• No response to last line of therapy: i. Progressive disease (PD) as best response to most recent therapy regimen; ii. Stable disease (SD) as best response to most recent therapy regimen
• Not candidate for autologous stem cell transplant (ASCT) or refractory post-ASCT: i. Disease progression (PD) or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy
• Individuals must have received adequate prior therapy including at a minimum:
• anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and
• an anthracycline containing chemotherapy regimen
• Immunohistochemical staining shows at least two of B cell surface receptor antigen CD19,CD20, BCMA are positive(including weak, medium and strong positive)
• At least one measurable lesion during the screening based on the recommendation for initial evaluation, staging and response assessment of Hodgkin and non-Hodgkin lymphoma.
• Life expectancy ≥ 12 weeks

You may not qualify if:

• Individuals who have antiCD45 or antiCD3 therapy
• Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of primary or secondary CNS (central nervous system) lymphoma, cerebrospinal fluid malignant cells or brain metastases
• Presence or history of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
• History of allogeneic stem cell transplantation
• Any of the following situations:
• HBsAg/ HBeAg positive; HBeAb/HBcAb positive and HBV(hepatitis B virus) DNA copies above the lower test limit;
• HCV(hepatitis C virus) RNA positive
• HIV(human immunodeficiency virus) positive or treponema pallidum positive
• Presence of active or life-threatening fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
• Individuals presence of unstable angina or myocardial infarction within 6 months of screening, or other severe/uncontrolled diseases during the screening (eg. Unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
• Presence of uncontrolled arrhythmia with treatment
• Pregnancy or breastfeeding women

Sponsors & Collaborators

• Shanghai Cell Therapy Group Co.,Ltd: lead

Study Sites (1)

Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, 201800, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jinxing Lou

  Shanghai Mengchao Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinxing Lou

CONTACT

021-67091399; loujx@shcell.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 6, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)