Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of YTB323. YTB323 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).

Official Title

Phase I, Open Label, Multicenter, Dose Escalation Study of YTB323 in Adult Patients With CLL/SLL, DLBCL and ALL

Keywords

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Diffuse Large B-cell Lymphoma; Acute Lymphoblastic Leukemia, CAR-T, ibrutinib, CLL, DLBCL, ALL, BLRM, YTB323, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, YTB323 and ibrutinib, YTB323 single agent, CLL/SLL, DLBCL

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Stanford University Medical Center accepting new patients
    Stanford California 94305-5826 United States
  • University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03960840
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 110 study participants
Last Updated