Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/2/2019 |
Start Date: | September 2016 |
End Date: | August 2033 |
A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Subjects With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
The primary objective of phase 1 is to evaluate the safety of axicabtagene ciloleucel and
atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the
efficacy of axicabtagene ciloleucel and atezolizumab, as measured by complete response rate
in subjects with refractory diffuse large B-cell lymphoma (DLBCL).
atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the
efficacy of axicabtagene ciloleucel and atezolizumab, as measured by complete response rate
in subjects with refractory diffuse large B-cell lymphoma (DLBCL).
Key Inclusion Criteria:
1. Histologically confirmed:
- Diffuse Large B Cell Lymphoma (DLBCL)
2. Chemotherapy-refractory disease, defined as one or more of the following:
- Stable disease (duration of stable disease must be less than or equal to 6
months) or progressive disease as best response to most recent chemotherapy
containing regimen
- Disease progression or recurrence less than or equal to 12 months of prior
autologous stem cell transplantation (SCT)
3. Individuals must have received adequate prior therapy including at a minimum:
- anti-CD20 monoclonal antibody unless investigator determines that tumor is
CD20-negative and
- an anthracycline containing chemotherapy regimen
4. At least one measurable lesion per revised IWG Response Criteria
5. Age 18 or older
6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
7. Adequate organ and bone marrow function
8. All Individuals or legally appointed representatives/caregivers, must personally sign
and date the IRB/IEC approved consent form before initiating any study specific
procedures or activities.
Key Exclusion Criteria:
1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g.
cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3
years
2. History of allogeneic stem cell transplantation
3. Prior CAR therapy or other genetically modified T cell therapy
4. Clinically significant active infection
5. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C
virus (anti-HCV positive)
6. Individuals with detectable cerebrospinal fluid malignant cells or brain metastases or
with a history of cerebrospinal fluid malignant cells or brain metastases
7. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,
cerebellar disease, or any autoimmune disease with CNS involvement
8. History of autoimmune disease. Patients with a history of autoimmune-related
hypothyroidism on a stable dose of thyroid replacement hormone and patients with
controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible for
this study.
9. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
pneumonitis per chest CT scan at screening. History of radiation pneumonitis in the
radiation field (fibrosis) is allowed.
10. Prior treatment with PD-L1 inhibitor, PD-1 inhibitor, anti-CTLA4, anti-CD137,
anti-OX40 or other immune checkpoint blockade or activator therapy with the exception
of Individuals who received atezolizumab in this study and are eligible for
re-treatment
11. Prior CD19 targeted therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
5
sites
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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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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