CD19-specific CAR-T Cells in CLL/SLL and DLBCL

• Status: Recruiting
• Trial end date: 2025-10-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a CD19-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (DLBCL) and in adult acute lymphoblastic leukemia (ALL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• ECOG performance status 0-1

• CLL or SLL diagnosis according to iwCLL criteria

• CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy

• DLBCL diagnosis by local histopathology

• DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)

• Refractory or relapsed CD19-positive ALL

• ALL with morphologic disease in the bone marrow

Exclusion Criteria:

• Prior CD19-directed therapy

• Prior administration of a genetically engineered cellular product

• Prior allogeneic HSCT

• Richter's transformation

• Active CNS lymphoma

• Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis