Clinical trial NCT03331198: Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Official title: An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Small Lymphocytic
Keywords: TRANSCEND_CLL_004
Lead sponsor: Juno Therapeutics, a Subsidiary of Celgene
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1: subjects will be assigned to receive JCAR017, or JCAR017 + ibrutinib, or JCAR017 + venetoclax Phase 2: subjects will be assigned to receive JCAR017 at the recommended dose
Primary purpose: TREATMENT

Brief summary: 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. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of:

  1. CLL with an indication for treatment based on the Investigator's opinion and 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 and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.
* Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:

  1. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
  2. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
  3. DEME cohort ONLY: Subjects with relapsed or refractory CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i.
* 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.
* Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax
* Subjects in venetoclax + JCAR017 combination cohort must:

  1. have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi
  2. be venetoclax naive (required for dose expansion) or
  3. if prior venetoclax (only for dose escalation)
  4. have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation
* subjects in the venetoclax + JCAR017 combination must have hemoglobin \>=9 g/dL, absolute neutrophil count \>=500mm3 and platelets\>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
* must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry

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 active 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 or covalent and non-covalent BTKi 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
* Progressive vascular tumor invasion, thrombosis, or embolism
* Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation
* Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.
* Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation
* For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued

Primary outcomes:
measure: Phase 1 JCAR017 monotherapy arm: adverse events
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 monotherapy arm: laboratory abnormalities
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm
timeFrame: Through post treatment up to Month 48
measure: Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse events
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalities
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm
timeFrame: Through post treatment up to Month 48
measure: Phase 2 JCAR017 monotherapy expansion arm
timeFrame: Through post treatment up to Month 48
measure: Phase 2 JCAR017 Double exposed monotherapy expansion arm: overall response rate (ORR)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: adverse events
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: laboratory abnormalities
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: ORR
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD negative response rate in peripheral blood
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD-negative CR rate in peripheral blood
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR)
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of complete response (DoCR)
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to response (TTR)
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to complete response (TTCR)
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: PFS
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: OS
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: adverse events
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: ORR
timeFrame: Through post treatment Day 90
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: MRD-negative response rate in peripheral blood
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: MRD-negative CR rate in peripheral blood
timeFrame: Through post treatment Day 90
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of response (DOR)
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of complete response (DoCR)
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to response (TTR)
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to complete response (TTCR)
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: PFS
timeFrame: Up to 48 months post treatment
measure: Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: OS
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: adverse events
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: laboratory abnormalities
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: ORR
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: MRD negative response rate in peripheral blood
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of response (DOR)
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of complete response (DoCR)
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: Time to response (TTR)
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: Time to complete response (TTCR)
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: PFS
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: OS
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: Health-related quality of life (HRQoL) questionnaire
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: HRQoL questionnaire
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: Health economics and outcomes research (HEOR) questionnaire
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire
timeFrame: Up to 48 months post treatment
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: adverse events
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: laboratory abnormalities
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Duration of response (DOR)
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: CR rate
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: MRD-negative response rate in peripheral blood
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Time to response (TTR)
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Time to complete response (TTCR)
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Progression free survival (PFS)
timeFrame: Up to approximately 24 months
measure: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Overall Survival (OS)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Duarte
country: United States
facility: City Of Hope
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: La Jolla
country: United States
facility: University Of California San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0059
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: Local Institution - 0010
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Newark
country: United States
facility: Local Institution - 0110
state: Delaware
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Local Institution - 0085
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0104
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0019
state: Georgia
city: Atlanta
country: United States
facility: The Blood and Marrow Transplant Group of Georgia (BMTGA)
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Chicago
country: United States
facility: University Of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT)
state: Indiana
city: Wichita
country: United States
facility: Local Institution - 0107
state: Kansas
city: Louisville
country: United States
facility: Norton Healthcare - Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Local Institution - 0027
state: Louisiana
city: Boston
country: United States
facility: Local Institution - 0005
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0015
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Ann Arbor
country: United States
facility: University Of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Local Institution - 0062
state: Michigan
city: Detroit
country: United States
facility: Local Institution - 0109
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: Basking Ridge
country: United States
facility: Local Institution - 0001
state: New Jersey
city: Edison
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System / Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Local Institution - 0077
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0035
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Local Institution - 0026
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Stony Brook
country: United States
facility: Local Institution - 0089
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center (Case Western)
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center (Stephenson Cancer Center)
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Eugene
country: United States
facility: Local Institution - 0098
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania - Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Clinical Research Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0029
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0083
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0079
state: Texas
city: Houston
country: United States
facility: The University of Texas - MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 0028
state: Utah
city: Charlottesville
country: United States
facility: Local Institution - 0113
state: Virginia
city: Richmond
country: United States
facility: Local Institution - 0087
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: Local Institution - 0018
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital BMT Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: Local Institution - 0112
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0112
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21.
citation: Siddiqi T, Soumerai JD, Dorritie KA, Stephens DM, Riedell PA, Arnason J, Kipps TJ, Gillenwater HH, Gong L, Yang L, Ogasawara K, Thorpe J, Wierda WG. Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL. Blood. 2022 Mar 24;139(12):1794-1806. doi: 10.1182/blood.2021011895.