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

Last Update: Feb 28, 2022

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
Start date 
Jun 27, 2019
Completion date 
Oct 09, 2025
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

Study Locations

United States
H Lee Moffitt Cancer Center and Research Institute
Recruiting
Tampa, 33612 - Florida
Contact: John Dewolfe (888-663-3488) - [email protected] - Javier Pinilla-Ibarz
United States
University of Chicago Medical Center Hematology and Oncology
Recruiting
Chicago, 60637 - Illinois
Contact: Elaine Hoekstra (773-834-8980) - [email protected] - Peter Riedell
United States
University of Kansas Cancer Center SC - CTL019C2201
Recruiting
Westwood, 66205 - Kansas
Contact: Morgan Albright (913-588-6029) - [email protected] - Leyla Shune
United States
Massachusetts General Hospital Cancer Center
Recruiting
Boston, 02114 - Massachusetts
Contact: Devin Walsh (617-726-2000) - [email protected] - Matthew Frigault
United States
University of Pennsylvania Clinical Studies Unit Perelman Center for Adv Med
Recruiting
Philadelphia, 19104 - Pennsylvania
Contact: Rachael Purri (215-615-6721) - [email protected] - Noelle Frey
United States
Sarah Cannon Research Institute Drug Ship - 4
Recruiting
Nashville, 37203 - Tennessee
Contact: David J Pruitt (615-329-7274) - [email protected] - Ian W. Flinn
United States
Medical College of Wisconsin, Inc.
Recruiting
Milwaukee, 53226 - Wisconsin
Contact: Nicole Raykovich (414-805-4600) - [email protected] - Nirav Shah
United States
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3004
Victoria
Australia
Austria
Novartis Investigative Site
Recruiting
Wien, A-1090
-
Austria
France
Novartis Investigative Site
Recruiting
Marseille, 13273
-
France
Novartis Investigative Site
Recruiting
Paris Cedex 10, 75475
-
France
Novartis Investigative Site
Recruiting
Pierre Benite Cedex, 69495
-
France
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Valencia, 46010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08041
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]