Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

Required: CD20 expression

positive for CD20 and/or CD22

Required: CD22 expression

positive for CD20 and/or CD22

Must have received: anti-CD20 monoclonal antibody — with anthracycline for DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, PMBCL, or transformed FL or MZL; with alkylating agent for FL

An Anti-CD20 MoAb and an anthracycline for DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, primary mediastinal large B-cell lymphoma (PMBCL), or transformed FL or MZL; An alkylating agent in combination with an anti-CD20 MoAb for FL

Must have received: anthracycline or bendamustine-containing chemotherapy regimen and a Bruton's tyrosine kinase (BTK) inhibitor — for mantle cell lymphoma (MCL)

An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton's tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)

Must have received: autologous anti-CD19 CAR T-cell therapy — if approved and available for the indicated lymphoma subtype, unless ineligible

Autologous anti-CD19 CAR T-cell therapy, if approved and available for the indicated lymphoma subtype, unless the subject is unable or is ineligible to receive approved autologous anti-CD19 CAR T-cell therapy (e.g., fail leukapheresis or manufacture, unable to wait for manufacture, CD19 negative disease, etc.)

Cannot have received: investigational product (except for cell or gene therapies and MoAbs)

Prior use of an investigational product (except for cell or gene therapies and MoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to start of LD regimen

Cannot have received: chemotherapy, biologic (except MoAbs), or targeted therapy

Previous approved therapy including chemotherapy, biologic (except MoAbs), or targeted therapy for R/R B-NHL with 5 half-lives or within 14 days, whichever is shorter, prior to start of the LD regimen

Cannot have received: monoclonal antibody

Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD

Cannot have received: systemic immunostimulatory agent

Prior systemic immunostimulatory agent within 3 half-lives prior to start of the LD regimen

Cannot have received: cell or gene therapy (approved or investigational)

Prior cell or gene therapy (approved or investigational) within 6 months of the start of LD

Cannot have received: cell or gene therapy (approved or investigational) targeting both CD20 and CD22

Prior cell or gene therapy (approved or investigational) targeting both CD20 and CD22

Cannot have received: autologous HSCT

Autologous HSCT infusion within 6 weeks of the start of LD

Cannot have received: allogeneic HSCT

Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD

Cannot have received: radiation therapy

Exception: except for palliative radiotherapy for specific on-target lesions

Radiotherapy within 8 weeks (except for palliative radiotherapy for specific on-target lesions) (prior to start of LD regimen)