A Study Evaluating the Safety and Efficacy of KITE-585 in Subjects With Relapsed/Refractory Multiple Myeloma
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/13/2019 |
Start Date: | October 31, 2017 |
End Date: | November 2033 |
A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects With Relapsed/Refractory Multiple Myeloma
To evaluate the safety and tolerability of KITE-585, an autologous engineered CAR T-cell
product targeting a protein commonly found on myeloma cells called BCMA. Patients will be
given a 3 day course of chemotherapy followed by a single infusion of KITE-585.
product targeting a protein commonly found on myeloma cells called BCMA. Patients will be
given a 3 day course of chemotherapy followed by a single infusion of KITE-585.
Participants with relapsed/refractory multiple myeloma can participate if all eligibility
criteria are met. Tests required to determine eligibility include disease assessments, a
physical exam, ECG and echocardiogram of the heart, brain MRI, and blood draws. Eligible
participants have white blood cells collected by apheresis. These cells are genetically
modified to make the experimental treatment KITE-585. Participants receive chemotherapy prior
to the KITE-585 infusion. After the KITE-585 infusion, participants will be followed for side
effects and effect of KITE-585 on their myeloma. Study procedures may be performed while
hospitalized and/or in the outpatient setting.
criteria are met. Tests required to determine eligibility include disease assessments, a
physical exam, ECG and echocardiogram of the heart, brain MRI, and blood draws. Eligible
participants have white blood cells collected by apheresis. These cells are genetically
modified to make the experimental treatment KITE-585. Participants receive chemotherapy prior
to the KITE-585 infusion. After the KITE-585 infusion, participants will be followed for side
effects and effect of KITE-585 on their myeloma. Study procedures may be performed while
hospitalized and/or in the outpatient setting.
Key Inclusion Criteria:
1. Measurable relapsed or refractory myeloma as defined by the International Myeloma
Working Group (IMWG) Consensus Criteria following treatment with at least 3 lines of
therapy including with both a proteasome inhibitor (PI) and an immunomodulatory drug
(IMiD), or progressive myeloma that is refractory to a regimen containing both a PI
and an IMiD.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
- Absolute neutrophil count (ANC) ≥ 1,000/µL
- Platelet count ≥ 75,000/µL
- Absolute lymphocyte count ≥ 100/µL
- Creatinine clearance above limits set in the protocol for each cohort
- Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
- Baseline oxygen saturation > 92% on room air and no clinically significant
pleural effusion
Key Exclusion Criteria:
1. Plasma cell leukemia
2. Non-secretory multiple myeloma
3. History of Central nervous system (CNS) involvement by multiple myeloma (MM)
4. Prior chimeric antigen receptor (CAR) therapy or other genetically modified T cells
5. Inadequate washout from prior therapy
6. Autologous stem cell transplant within 6 weeks before enrollment or any history of
allogenic transplant
7. History of active autoimmune disease
8. History of deep vein thrombosis or pulmonary embolism requiring systemic
anticoagulation within 6 months before enrollment
9. Recent history of other (non multiple myeloma) cancer
10. Active viral, fungal, bacterial or other infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
12
sites
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-4000
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: 800-811-8480
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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