Chronic Lymphocytic Leukemia Clinical Trial

CD19-specific CAR-T Cells in CLL/SLL, DLBCL and 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 leukemia-cll/" >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).

View Eligibility Criteria

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 is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

225

Study ID:

NCT03960840

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 30 Locations for this study

See Locations Near You

Stanford University Medical Center
Stanford California, 94305, United States More Info
Jhina Patro
Contact
650-725-0701
[email protected]
Lori Muffly
Principal Investigator
H Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States More Info
Brian James
Contact
888-663-3488
[email protected]
Javier Pinilla-Ibarz
Principal Investigator
Northside Hospital
Atlanta Georgia, 30342, United States More Info
Nancy Shegda
Contact
404-255-1930
[email protected]
Scott D. Solomon
Principal Investigator
Northwestern University Northwestern Memorial Hospital Trans
Chicago Illinois, 60611, United States More Info
Holly Roberta Krieg
Contact
[email protected]
Shira Dinner
Principal Investigator
University of Chicago Medical Center Hematology and Oncology
Chicago Illinois, 60637, United States More Info
Elaine Hoekstra
Contact
773-834-8980
[email protected]
Peter Riedell
Principal Investigator
University of Kansas Cancer Center SC - CTL019C2201
Westwood Kansas, 66205, United States More Info
Claire McCann
Contact
913-588-6029
[email protected]
Leyla Shune
Principal Investigator
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States More Info
Kristofer Soltys
Contact
617-726-2000
[email protected]
Matthew Frigault
Principal Investigator
University of Pennsylvania Clinical Studies Unit Perelman Center for Adv Med
Philadelphia Pennsylvania, 19104, United States More Info
Rachael Purri
Contact
215-615-6721
[email protected]
Noelle Frey
Principal Investigator
Sarah Cannon Research Institute Drug Ship - 4
Nashville Tennessee, 37203, United States More Info
Katie J Serena
Contact
615-329-7274
[email protected]
Ian W. Flinn
Principal Investigator
Uni of TX MD Anderson Cancer Cntr
Houston Texas, 77030, United States More Info
Michael Leonard
Contact
713-792-2921
[email protected]
Nitin Jain
Principal Investigator
Medical College of Wisconsin, Inc.
Milwaukee Wisconsin, 53226, United States More Info
Jessica Neumann
Contact
414-805-4600
[email protected]
Nirav Shah
Principal Investigator
Novartis Investigative Site
Melbourne Victoria, 3000, Australia
Novartis Investigative Site
Melbourne Victoria, 3004, Australia
Novartis Investigative Site
Wien , A-109, Austria
Novartis Investigative Site
Marseille , 13273, France
Novartis Investigative Site
Paris Cedex 10 , 75475, France
Novartis Investigative Site
Pierre Benite Cedex , 69495, France
Novartis Investigative Site
Frankfurt , 60590, Germany
Novartis Investigative Site
Koeln , 50937, Germany
Novartis Investigative Site
Bergamo BG, 24128, Italy
Novartis Investigative Site
Bologna BO, 40138, Italy
Novartis Investigative Site
Milano MI, 20132, Italy
Novartis Investigative Site
Fukuoka city Fukuoka, 812-8, Japan
Novartis Investigative Site
Sapporo city Hokkaido, 060 8, Japan
Novartis Investigative Site
Bunkyo ku Tokyo, 113-8, Japan
Novartis Investigative Site
Sevilla Andalucia, 41013, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
Barcelona , 08041, Spain
Novartis Investigative Site
Madrid , 28009, Spain

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

225

Study ID:

NCT03960840

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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