This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready to use, which can save time and reduce costs. It targets two proteins, CD19 and CD20, to lower the chance of relapse and uses gene editing to make it safer. The trial has three parts: first to find a safe dose, then to confirm it, and finally to test how well it works in patients with diffuse large B-cell lymphoma (DLBCL). Patients will get one infusion after chemotherapy to prepare their body. The main goal is to check safety and see how many patients have a complete response by Week 13. About 160 patients will take part, and researchers will follow them for up to 15 years.
Adults 18 years or older.
Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL).
Must have received at least 2 prior lines of therapy.
ECOG performance status 0-1 (able to carry out daily activities).
Active CNS involvement (including PCNSL) in dose escalation cohorts; may be allowed in later cohorts with Sponsor approval.
Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T.
Autologous stem cell transplant within 3 months.
Prior allogeneic stem cell transplant or solid organ transplant.
Single group
Cyclophosphamide (Non-IMP, Lymphodepletion)
Other interventionIntravenous infusion over 3 days (d-5 to d-3)
Fludarabine (Non-IMP, Lymphodepletion)
Other interventionIntravenous infusion over 3 days (d-5 to d-3)
Allo-QuadCAR01-T
DrugSingle dose IV infusion on Day 1
Incidence of AEs defined as DLTs
Incidence and intensity of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), tumor lysis syndrome, and graft versus host disease (GvHD), which will be graded according to widely accepted specialized criteria
To determine the maximum tolerated dose (MTD)
MTD
To determine the incidence of dose-limiting toxicities (DLT)
Incidence of DLTs
Phase 2: Complete response rate (CRR)
Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.
Pharmacokinetics of Allo-QuadCAR01-T in PB in patients after infusion of Allo-QuadCAR01-T
Detection of VCN in blood samples
To investigate the impact of Allo-QuadCAR01-T on MRD
MRD levels in responding CLL patients
To evaluate immunogenicity against Allo-QuadCAR01-T
Incidence of ADA1 formation against anti-CD19/CD20 ECD and ADA2 formation against the RevCAR ECD of Allo-QuadCAR01-T
To evaluate host immune cell depletion and reconstitution resulting from LD
Enumeration of host PB B-cell, T cell, and NK cell numbers
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AvenCell Therapeutics, Inc.
Lead sponsor
AvenCell Europe GmbH
Collaborator
