A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Eastern cooperative oncology group (ECOG) performance status of 0 or 1

• Adequate renal, hepatic, pulmonary and cardiac function defined as:

‣ Renal function: Serum creatinine ≤ 1.5 upper limit of normal(ULN), or eGFR ≥ 60 mL/min/1.73m2 \[eGFR(estimated glomerular filtration rate)=186×age\^-0.203×SCr\^-1.154(mg/dl),female×0.742\]

⁃ Hepatic function: i: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 ULN and ii: total bilirubin ≤ 2 ULN, except in individuals with Gilbert syndrome (in Gilbert's syndrome patients, those with total bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN can be enrolled).iii: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN Pulmonary: Have the minimum level of pulmonary reserve, defined as ≤ CTCAE (Common Terminology Criteria for Adverse Events) grade 1 dyspnea and the SaO2(oxygen saturation)≥ 91% on room air

⁃ Cardiac: left ventricular ejection fraction (LVEF) ≥50% determined by echocardiogram(ECG) or multigated acquisition scan (MUGA)

• Adequate bone marrow function, define as:

‣ absolute neutrophil count (ANC) ≥1 ×10\^9/L

⁃ absolute lymphocyte count (ALC)≥ 0.5 ×10\^9/L

⁃ Platelets ≥50 ×109/L;

⁃ Hemoglobulin ≥80 g/L; patients with bone marrow involvement can be enrolled if globulin\>60 g/L

• Female of child-bearing age and male participants must agree to use effective contraceptive methods until no CAR-T cells can be detected by PCR(polymerase chain reaction) test.

Locations
Other Locations
China
Mengchao Cancer Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jinxing Lou
loujx@shcell.com
021-67091399
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: CD19/CD20/BCMA CAR T therapy
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
Related Therapeutic Areas
Sponsors
Leads: Shanghai Cell Therapy Group Co.,Ltd

This content was sourced from clinicaltrials.gov