Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)



Status:Recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:December 26, 2017
End Date:March 1, 2022
Contact:Juno Medical Information
Email:medicalinformation@junotherapeutics.com
Phone:866-599-JUNO (5866)

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An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of
JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a
Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with
relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy
and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1
cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the
safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.


Inclusion Criteria:

- Diagnosis of:

1. CLL with an indication for treatment based on iwCLL guidelines and clinical
measurable disease, or

2. SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B
lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable
disease that is biopsy-proven SLL)

- Subjects (other than those in the ibrutinib + JCAR017 combination therapy arm) must
have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have
been deemed ineligible for BTKi therapy.

- Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must
have received previous treatment as follows:

1. Subjects with CLL or SLL and high-risk features must have failed at least 2 lines
of prior therapy.

2. Subjects with CLL or SLL and standard-risk features must have failed at least 3
lines of prior therapy.

- Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:

1. be receiving ibrutinib and progressing at the time of study enrollment

2. be receiving ibrutinib for at least 6 months with a response less than complete
response/remission (CR) and have high-risk features as defined in inclusion
criterion 5a

3. have BTK or PLCgamma2 mutations per local laboratory assessment, with or without
progression on ibrutinib

4. have previously received ibrutinib and have no contraindications to restarting
ibrutinib

- Eastern Cooperative Oncology Group performance status of ≤ 1

- Assessed by the Investigator to have adequate bone marrow function to receive
lymphodepleting chemotherapy

- Adequate organ function, defined as:

1. Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated
creatinine clearance > 30 mL/min

2. Alanine aminotransferase ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0
mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)

3. Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse
Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air

4. Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as
assessed by echocardiogram or multiple uptake gated acquisition scan performed
within 30 days prior to determination of eligibility

- Subject either currently has central vascular access or is a candidate to receive
central vascular access or peripheral vascular access for leukapheresis procedure.

- If prior CD19-targeted therapy has been administered, subject must have CD19-positive
disease confirmed by immunohistochemistry or flow cytometry since completing the prior
CD19-targeted therapy.

Exclusion Criteria:

- Subjects with known active central nervous system (CNS) involvement by malignancy.
Those with prior CNS disease that has been effectively treated will be eligible if
treatment was completed at least 3 months prior to enrollment with no evidence of
symptomatic disease and stable abnormalities on repeat imaging.

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

- Subjects with Richter's transformation

- Prior treatment with any gene therapy product

- Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV)
infection

- Systemic fungal, bacterial, viral, or other infection that is not controlled

- Presence of acute or extensive chronic graft versus host disease (GVHD)

- History of any one of the following cardiovascular conditions within the past 6
months: Class III or IV heart failure as defined by the New York Heart Association
(NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or
other clinically significant cardiac disease

- History or presence of clinically relevant CNS pathology such as epilepsy, generalized
seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain
injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or
psychosis

- Pregnant or nursing (lactating) women

- Use of any of the following medications or treatments within the noted time prior to
leukapheresis:

1. Alemtuzumab within 6 months prior to leukapheresis

2. Allogeneic hematopoietic stem cell transplant within 100 days prior to
leukapheresis

3. Cladribine within 3 months prior to leukapheresis

4. Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis

5. Radiation including large bone marrow fields such as sternum or pelvis within 6
weeks prior to leukapheresis

6. Fludarabine within 4 weeks prior to leukapheresis

7. GVHD therapies such as calcineurin inhibitors, methotrexate or other
chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive
antibodies (such as anti-tumor necrosis factor-α [TNFα], anti-interleukin-6
[IL-6], or anti-interleukin-6 receptor [IL 6R]) within 4 weeks prior to
leukapheresis

8. Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2
weeks prior to leukapheresis

9. Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or
equivalent) within 7 days prior to leukapheresis

10. Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis

11. Venetoclax within 4 days prior to leukapheresis

12. Idelalisib or duvelisib within 2 days prior to leukapheresis

13. Lenalidomide within 1 day prior to leukapheresis

14. Experimental agents, including off-label use of approved drugs (with the
exception of acalabrutinib which may be continued up to the day before
leukapheresis), within 4 weeks prior to leukapheresis unless progression is
documented on the experimental therapy and at least 3 half-lives have elapsed
prior to leukapheresis

- Uncontrolled medical, psychological, familial, sociological, or geographical
conditions that do not permit compliance with the protocol, as judged by the
Investigator; or subject unwillingness or inability to follow the procedures required
in the protocol

- Tumor invasion of venous or arterial vessels

- Deep vein thrombosis or pulmonary embolism within 3 months prior to leukapheresis

- Deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic
anticoagulation
We found this trial at
17
sites
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: William G Wierda, MD, PhD
Phone: 713-792-7026
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Jacob D Soumerai, MD
Phone: 617-724-4000
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Jon Arnason, MD
Phone: 617-667-5984
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: David Maloney, MD, PhD
Phone: 206-606-4668
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Peter Riedell, MD
Phone: 773-702-2070
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Shuo Ma, MD, PhD
Phone: 312-695-6180
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Duarte, California 91010
Principal Investigator: Tanya Siddiqi, MD
Phone: 626-256-4673
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Gilbert, Arizona 85234
Principal Investigator: Javier J Munoz, MD
Phone: 480-256-3425
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Gilbert, AZ
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Tatyana Feldman, MD
Phone: 551-996-5168
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: Thomas J Kipps, MD, PhD
Phone: 858-246-0386
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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New York, New York 10021
Principal Investigator: Koen Van Besien, MD, PhD
Phone: 212-746-2651
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Nicole Lamanna, MD
Phone: 212-304-5558
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Julie Vose, MD
Phone: 402-559-3853
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Matthew Carabasi, MD
Phone: 215-955-3758
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Kathleen Dorritie, MD
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Salt Lake City, Utah 84112
Principal Investigator: Deborah Stephens, DO
Phone: 801-587-7604
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San Francisco, California 94143
Principal Investigator: Lawrence Kaplan, MD
Phone: 415-476-2351
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