Clinical Trials Logo

Clinical Trial Summary

This is an open-label, multicenter, dose-escalation phase 1 study to determine the safety and efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma.


Clinical Trial Description

This is an open-label, multicenter, phase 1 study to determine the safety and antitumor activity of BZ019 in adult patients with R/R large B cell lymphoma (DLBCL),including: DLBCL, not otherwise specified (NOS), transformed DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements and primary mediastinal B-cell lymphoma (PMBCL).The safety and efficacy of a single dose of different target doses of BZ019 will be evaluated in the dose-escalation phase and dose-expansion phase.

Upon enrollment, subjects will undergo leukapheresis to enable BZ019 product generation. A baseline tumor biopsy (in subjects with accessible disease) and bone marrow aspirate and biopsy will be obtained.

Upon successful BZ019 product generation, subjects will enter the treatment phase and receive BZ019 infusion. A completed treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 infusion. BZ019 will be administered 2 to 14 days after the completion of lymphodepleting chemotherapy.

After the infusion of BZ019, subjects will be in the follow-up period upon 12 months for evaluation the safety and efficacy of BZ019. Subjects will be followed for long-term safety, overall survival even after disease progression. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04067414
Study type Interventional
Source Institute of Hematology & Blood Diseases Hospital
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 14, 2018
Completion date December 31, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04670029 - Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line Phase 3
Active, not recruiting NCT04572763 - Copanlisib Plus Venetoclax in R/R DLBCL Phase 1/Phase 2
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Completed NCT03287817 - CD19/22 CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma Phase 1/Phase 2
Enrolling by invitation NCT05645744 - Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
Completed NCT04316624 - A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy Phase 1
Active, not recruiting NCT04555811 - FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL Phase 1
Terminated NCT04189952 - Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma Phase 2
Recruiting NCT01949818 - Treatment of Diffuse Large B Cell Lymphoma Phase 4
Completed NCT01459887 - Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma Phase 3
Completed NCT03242902 - To Decrease Fatigue With Light Therapy Phase 3
Recruiting NCT04104776 - A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas Phase 1/Phase 2
Recruiting NCT05018520 - The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk Phase 3
Withdrawn NCT04052061 - QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma Phase 1
Recruiting NCT05020392 - Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma Phase 3
Recruiting NCT05006716 - A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies Phase 1/Phase 2
Completed NCT03297424 - A Study of PLX2853 in Advanced Malignancies. Phase 1
Recruiting NCT04545762 - Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma Phase 1