A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Description

This study will enroll approximately 50 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

Study Start Date

May, 10 2017

Estimated Completion Date

July 2023

Interventions

  • Biological: KTE-C19

Study ID

Kite Pharma, Inc. -- KTE-C19-105

Status

Recruiting

Trial ID

NCT03105336

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

50

Sponsor

Kite Pharma, Inc.

Inclusion Criteria

  • 1) Subject has [follicular lymphoma that has progressed within 24 months of first diagnosis and treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP) OR Progression of iNHL within 6 months of completion of second or later line therapy containing both an anti-CD20 antibody and alkylating agent OR Progression of iNHL at any point following autologous transplantation. 2) Subject has [measurable disease]. 3) Subject has no known presence or history of CNS involvement by lymphoma. 4) If subject is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, subject is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis. 5) Subject has ECOG performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function 6) Subject is not pregnant or breastfeeding (female subjects only) and is willing to use birth control from the time of consent through 6 months following CAR T cell infusion (both male and female subjects).B24

Exclusion Criteria

  • 1) Transformed FL 2) Small lymphocytic lymphoma 3) Histological Grade 3b FL 4) Subject will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant. 5) Subject has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (10)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Krystle Benedict 617-582-8713 Krystle_Benedict@dfci.harvard.edu
University of Rochester Medical Center URMC - Rochester, New York 335.8 miles Frances Batarse 585-275-5825 frances_batarse@urmc.rochester.edu
University of Rochester Medical Center URMC - Rochester, New York 335.8 miles Frances Batarse 585-275-5825 frances_batarse@urmc.rochester.edu
University of Rochester Medical Center URMC - Rochester, New York 335.8 miles Frances Batarse 585-275-5825 frances_batarse@urmc.rochester.edu
UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania 478.5 miles Linda Fukas None fukaslj@upmc.edu
H Lee Moffitt Cancer Center - Tampa, Florida 1,178.7 miles Matthew Scott None matthew.scott@moffitt.org
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Liliana Vallejo None lnvallejo@mdanderson.org
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles David Maloney Dr 206-667-5616 dmaloney@fredhutch.org
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles David Maloney Dr 206-667-5616 dmaloney@fredhutch.org
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles David Maloney Dr 206-667-5616 dmaloney@fredhutch.org

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