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

  • Interventional
  • Recruiting
  • NCT03960840
Eligibility Details Visit Clinicaltrials.gov

Phase I, Open Label, Multicenter, Dose Escalation Study of CD19-specific CAR-T Cells in Adult Patients With CLL/SLL and DLBCL

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).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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)

        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

         - Anti-CD20 monoclonal antibodies within 4 weeks prior to infusion

At a Glance

National Government IDNCT03960840

IRB#IRB19-0648

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianPeter Riedell

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting