Open-Label Dose-Finding and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 (in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin s Lymphoma (B-NHL).
DOSE-FINDING PART
Primary Objectives:
To assess the safety and tolerability and determine the MTD and/or RP2D of UCART20x22 in subjects with R/R mature B-NHL.
Secondary Objectives:
- To assess the antitumor activity of UCART20x22 in subjects with R/R mature B-NHL.
- To identify the optimal lymphodepletion (LD) regimen to evaluate in dose-expansion part cohort(s).
- To measure the development of an immune response to alemtuzumab (CLLS52) at a central laboratory.
- To evaluate the pharmacokinetics (PK) alemtuzumab (CLLS52) at a central laboratory.
- To evaluate the pharmacodynamics (PD) of alemtuzumab (CLLS52) at a central laboratory.
DOSE-EXPANSION PART
Primary Objectives:
- To assess the safety and tolerability of UCART20x22 and confirm the RP2D in subjects with R/R LBCL.
Secondary Objectives:
- To assess the antitumor activity of UCART20x22 in subjects with specific subtypes of R/R LBCL.
- To measure the development of an immune response to alemtuzumab (CLLS52) at a central laboratory.
- To evaluate the PK of alemtuzumab (CLLS52) at a central laboratory.
- To evaluate the PD of alemtuzumab (CLLS52) at a central laboratory.
DOSE-FINDING AND DOSE-EXPANSION PARTS
Exploratory Objectives:
- To characterize the expansion, trafficking, phenotype, and persistence of UCART20x22.
- To assess cytokine, chemokine, and other soluble factor levels before and after UCART20x22 administration.
- To measure the development of an immune response to UCART20x22.
- To investigate the potential relationship between CD20 and CD22 expression levels on lymphoma cells and clinical outcome.
- To investigate the role of the tumor microenvironment, CAR T-cell infiltration into the tumor, and clinical outcome.
- To confirm the absence of RCL.
- To assess minimal residual disease (MRD) negativity rate post UCART20x22 administration by a genomic assay.
- Rutgers University
Inclusion Criteria: - B-ALL blast cells expressing CD22 - Diagnosed with R/R B-ALL - Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen Exclusion Criteria: -Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to enrollment
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.