A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting

Conditions:Cancer, Lymphoma, Lymphoma, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - Any
Start Date:November 29, 2018
End Date:January 29, 2022
Contact:Juno Therapeutics
Phone:1-866-599-JUNO (5866)

Use our guide to learn which trials are right for you!

This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy
of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory
to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the
outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up
to 2 years.

This is an open-label, multicenter, Phase 2 study to assess the safety and antitumor activity
in adult patients with relapsed or refractory B-cell non-Hodgkin Lymphoma when administered
with lisocabtagene maraleucel (JCAR017) in the outpatient setting.

Upon the successful product generation of lisocabtagene maraleucel, subjects will enter the
treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by
lisocabtagene maraleucel administration. Subjects will then enter the post-treatment
follow-up phase of the study and will be followed for approximately 24 months for safety,
disease status, health-related quality of life (HRQoL), and survival. Long-term follow-up
will continue under a separate long-term follow-up protocol, per health regulatory authority
guidelines, currently up to 15 years after the last lisocabtagene maraleucel administration.

Inclusion Criteria:

- Age ≥ 18 years at the time of consent

- Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell
lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL
from follicular lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6
rearrangements with DLBCL histology. Subjects must have been treated with an
anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or
refractory disease after at least 2 systemic lines of therapy for DLBCL or after

- Positron-emission tomography-positive disease by Lugano Classification

- Eastern Cooperative Oncology Group performance status of 0 to 1

- Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function

- Adequate vascular access for leukapheresis procedure

- Subjects who have received previous CD19-targeted therapy must have CD19-positive
lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy

- Subjects must agree to use appropriate contraception.

Exclusion Criteria:

- Subjects with central nervous system (CNS)-only involvement by malignancy (note:
subjects with secondary CNS involvement are allowed on study)

- History of prior allogeneic hematopoietic stem cell transplant

- Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with
fludarabine or cladribine within 3 months of leukapheresis

- History of another primary malignancy that has not been in remission for at least 2
years.The following are examples of exceptions from the 2-year limit: nonmelanoma skin
cancer, definitively-treated stage 1 solid tumor with a low risk of recurrence,
curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy
or a squamous intraepithelial lesion on a Papanicolau smear.

- Active hepatitis B or hepatitis C infection at the time of screening

- History of or active human immunodeficiency virus infection at the time of screening

- Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate
anti-infection treatment at the time of leukapheresis or lisocabtagene maraleucel

- Presence of acute or chronic graft-versus-host disease

- History of clinically significant cardiac conditions within the past 6 months

- History or presence of clinically relevant CNS pathology such as epilepsy/seizure,
paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease,
cerebellar disease, organic brain syndrome, or psychosis

- Pregnant or nursing women.

- Subject does not meet protocol-specified washout periods for certain prior treatments

- Prior CAR T-cell or other genetically modified T-cell therapy
We found this trial at
San Antonio, Texas 78229
Principal Investigator: Cesar Freytes, MD
Phone: 210-575-4238
San Antonio, TX
Click here to add this to my saved trials
4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: John Godwin, MD
Phone: 503-215-2608
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
Portland, OR
Click here to add this to my saved trials
1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Principal Investigator: Michael Maris, MD
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
Denver, CO
Click here to add this to my saved trials
8631 West 3rd Street
Los Angeles, California 90048
Principal Investigator: Yuliya Linhares, MD
Phone: 310-967-8594
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
Principal Investigator: Don A Stevens, MD
Phone: 502-899-3366
Louisville, KY
Click here to add this to my saved trials
Morristown, New Jersey 07962
Principal Investigator: Mohamad Cherry, MD
Phone: 973-971-5235
Morristown, NJ
Click here to add this to my saved trials
Nashville, Tennessee 37203
Principal Investigator: Carlos Bachier, MD
Phone: 615-986-7600
Nashville, TN
Click here to add this to my saved trials