Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR20A in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Verified date | January 2023 |
Source | Precision BioSciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL or r/r CLL/SLL.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 24, 2021 |
Est. primary completion date | June 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria Criteria for NHL: - r/r CD20+ B-cell NHL that is histologically confirmed by archived tumor biopsy tissue from the last relapse and corresponding pathology report. - Measurable or detectable disease according to the Lugano classification. - Primary refractory disease or r/r disease after a response to 2 prior regimens. Criteria for CLL/SLL: - Diagnosis of CD20+ CLL with indication for treatment based on the iwCLL guidelines and clinically measurable disease or SLL with measurable disease that is biopsy-proven SLL. - Previously failed/tolerant to at least 2 prior lines of systemic targeted therapy of known benefit. Criteria for both NHL and CLL/SLL: - Study participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. - Study participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function. Key Exclusion Criteria: Criteria for NHL: - Requirement for urgent therapy due to mass effects such as bowel obstruction, spinal cord, or blood vessel compression. - Active central nervous system (CNS) disease. A negative computed tomography (CT)/magnetic resonance imaging (MRI) is required at Screening if the study participant has a history of CNS lymphoma. Criteria for NHL and CLL/SLL: - Active CNS disease. A negative lumbar puncture is required at Screening if the study participant has a history of CNS disease. - Previous malignancy, besides the malignancies of inclusion (B-cell NHL or CLL/SLL), that in the investigator's opinion, has a high risk of relapse in the next 2 years. - Active uncontrolled fungal, bacterial, viral, protozoal, or other infection. - Any form of primary immunodeficiency. - History of human immunodeficiency virus (HIV) infection. - Active hepatitis B or C. - Uncontrolled cardiovascular disease. - Hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening. - Presence of a CNS disorder that renders ineligible for treatment. - History of a genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman Diamond syndrome, or any other known bone marrow failure syndrome. - Received ASCT within 45 days of Screening if the study participant has met the rest of the count requirements. - Must not have received systemic corticosteroid therapy for at least 7 days prior to initiating lymphodepletion chemotherapy. - Received a live vaccine within 4 weeks before Screening. - Radiotherapy within 4 weeks determined on a case-by-case basis. - Presence of a pleural/peritoneal/pericardial catheter. - Current use of any anticoagulant or antiplatelet therapy. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
United States | City of Hope | Duarte | California |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Columbia University | New York | New York |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Precision BioSciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) | The maximum tolerated dose (MTD) is the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy. | Day 1 to Day 28 | |
Primary | Number of Participants With Dose-Limiting Toxicities | Dose-limiting toxicities (DLT) are certain Grade 3 and Grade 4 toxic reactions as defined by the protocol and CTCAE v5.0. | 1 year | |
Secondary | Objective Response Rate | Objective response rate (ORR) is a measure of clinical activity as response in NHL by the revised Lugano Classification (Cheson et al, 2016) or a response in CLL/SLL by the International Workshop on Chronic Lymphocytic Leukemia 2018 guidelines. | 1 year | |
Secondary | Progression-free Survival (PFS) | Progression-free survival is defined as the duration (days) from Day 0 to disease progression or death. | 1 year |
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