Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:December 2015
End Date:December 2020
Contact:Juno Therapeutics
Phone:1-866-599-JUNO (5866)

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A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of
modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell
NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety
and antitumor activity. We will also determine how long the modified T cells stay in the
patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma
whose disease has come back or has not responded to treatment.

This is an open-label, multicenter Phase 1 study to determine the safety, pharmacokinetics
(PK), and antitumor activity of JCAR017 in adult patients with relapsed or refractory diffuse
large B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular
lymphoma Grade 3B, and mantle cell lymphoma (MCL). This study will evaluate and refine the
dose and schedule of JCAR017 to optimize safety and antitumor activity. A dose-confirmation
group or groups will further evaluate the safety and efficacy of JCAR017 at the recommended

Upon successful generation of JCAR017 product, participants will receive treatment with one
or more cycles of JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy
followed by one or two doses of JCAR017 administered by intravenous (IV) injection.

The follow-up period for each participant is approximately 24 months after the final JCAR017
infusion. Long-term follow-up for survival, toxicity, and viral vector safety will continue
under a separate long-term follow-up protocol per health regulatory authority guidelines,
currently up to 15 years after the last JCAR017 infusion.

Inclusion Criteria:

1. Age ≥18 years

2. Relapsed or refractory B-cell NHL, including

1. DLBCL cohort: DLBCL, not otherwise specified (NOS; includes transformed DLBCL
from indolent histology [tDLBCL]), high-grade B-cell lymphoma with MYC and BCL2
and/or BCL6 rearrangements with DLBCL histology (Swerdlow 2016), primary
mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B. 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
lines of therapy or after auto-HSCT.

2. MCL cohort: MCL (diagnosis must be confirmed with cyclin D1 expression or
evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization [FISH],
or PCR) with relapsed or refractory disease after at least 1 prior line of MCL

3. PET-positive disease by Lugano classification

4. Archived tumor biopsy tissue available from the last relapse and corresponding
pathology report available or, if at least one tumor-involved site is deemed
accessible at time of screening, willing to undergo pre-treatment biopsy (excisional
when possible) for disease confirmation. If a subject has never had a complete
response, a sample from the most recent biopsy is acceptable.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

6. Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function

7. Adequate vascular access for leukapheresis procedure

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

9. Participants must agree to use appropriate contraception.

Exclusion Criteria:

1. Active central nervous system (CNS)-only involvement by malignancy (note: participants
with secondary CNS involvement are allowed on study)

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

3. Treatment with alemtuzumab within 6 months of leukapheresis or fludarabine or
cladribine within 3 months of leukapheresis

4. Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection

5. Uncontrolled systemic fungal, bacterial, viral, or other infection

6. Presence of graft-vs-host disease (GVHD)

7. History of cardiovascular disease

8. 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

9. Pregnant or nursing women

10. Use of the following:

- Therapeutic doses of corticosteroids (defined as >20 mg/day prednisone or
equivalent) within 7 days of leukapheresis or 72 hours prior to JCAR017
administration. Physiologic replacement, topical, and inhaled steroids are

- Low dose chemotherapy (e.g., vincristine, rituximab, cyclophosphamide ≤300 mg/m2)
given after leukapheresis to maintain disease control must be stopped ≥7 days
prior to lymphodepleting chemotherapy.

- Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below)
within 1 week of leukapheresis. Oral chemotherapeutic agents, including
lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed
prior to leukapheresis.

- Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosofamide,
bendamustine) within 2 weeks of leukapheresis.

- Experimental agents within 4 weeks of leukapheresis unless no response or disease
progression is documented on the experimental therapy and at least 3 half-lives
have elapsed prior to leukapheresis

- Immunosuppressive therapies within 4 weeks of leukapheresis and JCAR017
administration (e.g., calcineurin inhibitors, methotrexate or other
chemotherapeutics, mycophenolyate, rapamycin, thalidomide, immunosuppressive
antibodies such as anti-TNF, anti IL6, or anti-IL6R)

- Donor lymphocyte infusions (DLI) within 6 weeks of JCAR017 administration

- Radiation within 6 weeks of leukapheresis. Subjects must have progressive disease
in irradiated lesions or have additional non-irradiated, PET-positive lesions to
be eligible. Radiation to a single lesion, if additional non-irradiated
PET-positive lesions are present, is allowed up to 2 weeks prior to

- Allo-HSCT within 90 days of leukapheresis

11. Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of
prior JCAR017 treatment in this protocol for subjects receiving retreatment
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