Dose-escalation Study of Safety of PBCAR0191 in Patients With r/r NHL and r/r B-cell ALL
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|ClinicalTrials.gov Identifier: NCT03666000|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin Lymphoma B-cell Acute Lymphoblastic Leukemia||Genetic: PBCAR0191 Drug: Fludarabine Drug: Cyclophosphamide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2a, Open-label, Dose-escalation/Expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma and r/r B-cell Acute Lymphoblastic Leukemia|
|Actual Study Start Date :||March 11, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||June 2021|
In this study, PBCAR0191, allogeneic anti-CD19 CAR T Cells, is used to treat patients with relapsed or refractory (r/r) Non-Hodgkin Lymphoma and r/r B-cell Acute Lymphoblastic Leukemia.
Route of Administration: Intravenous infusion.
Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR0191 infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
Single dose of Allogeneic Anti-CD19 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
Other Name: Allogeneic Anti-CD19 CAR T cells
Fludarabine is used for lymphodepletion.
Cyclophosphamide is used for lymphodepletion.
- Maximum Tolerated Dose (MTD) [ Time Frame: Day 1 - Day 28 ]To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy.
- Number of Participants with Dose Limiting Toxicity(ies) [ Time Frame: 1 year ]To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
- Objective Response Rate of Patients [ Time Frame: 1 year ]To assess clinical activity as response in B-ALL by the NCCN Guidelines on ALL (NCCN, 2017) and in NHL by the revised Lugano Classification (Cheson et al, 2016), both reported as objective response rate.
- Area Under the Curve [AUC] [ Time Frame: Up to 1 year ]To evaluate Area Under the Curve [AUC] of PBCAR0191 in patients tested.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666000
|Contact: Clinical Precision BioSciences, Inc.||email@example.com|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Clinical Research 626-218-1133|
|United States, Florida|
|H. Lee Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Clinical Research 888-663-3488|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Clinical Trials 877-338-7425|
|United States, Texas|
|MD Anderson||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research 855-761-8004|
|Study Chair:||Chris Heery, MD||Precision BioSciences, Inc.|