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

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

ClinicalTrials.gov Identifier: NCT03960840

Novartis Reference Number: CYTB323A12101

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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).

Condition 
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Diffuse Large B-cell Lymphoma; Acute Lymphoblastic Leukemia
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
110 participants
Start date 
Jun 27, 2019
Completion date 
Mar 27, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
YTB323 and ibrutinib
Single infusion of YTB323 and daily ibrutinib
Drug
YTB323 single agent
Single infusion of YTB323

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

Study Locations

United States
University of Chicago Medical Center Hematology and Oncology
Recruiting
Chicago, 60637
Illinois
United States
University of Kansas Cancer Center SC - CTL019C2201
Recruiting
Westwood, 66205
Kansas
United States
Sarah Cannon Research Institute Drug Ship - 4
Recruiting
Nashville, 37203
Tennessee
United States
Medical College of Wisconsin, Inc.
Recruiting
Milwaukee, 53226
Wisconsin
United States
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]