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History of Changes for Study: NCT04030195
To Evaluate the Safety and Tolerability, Find an Appropriate Dose to Optimize Safety and Efficacy, and Evaluate 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)
Latest version (submitted June 17, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 22, 2019 None (earliest Version on record)
2 March 13, 2020 Recruitment Status, Arms and Interventions, Study Design, Study Status, Study Description, Contacts/Locations, Oversight and Study Identification
3 March 27, 2020 Study Status and Arms and Interventions
4 April 28, 2020 Study Status and Contacts/Locations
5 June 1, 2020 Study Status and Contacts/Locations
6 June 10, 2020 Contacts/Locations and Study Status
7 July 28, 2020 Contacts/Locations, Study Status and Conditions
8 September 11, 2020 Study Status and Contacts/Locations
9 October 29, 2020 Study Status and Contacts/Locations
10 April 28, 2021 Contacts/Locations and Study Status
11 June 17, 2022 Recruitment Status, Study Status, Contacts/Locations, Study Design, Arms and Interventions, Study Description, Eligibility and Study Identification
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Study NCT04030195
Submitted Date:  July 22, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: PBCAR20A-01
Brief Title: To Evaluate the Safety and Tolerability, Find an Appropriate Dose to Optimize Safety and Efficacy, and Evaluate 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)
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 Study Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2019
Overall Status: Not yet recruiting
Study Start: October 2019
Primary Completion: May 2020 [Anticipated]
Study Completion: February 2021 [Anticipated]
First Submitted: July 19, 2019
First Submitted that
Met QC Criteria:
July 22, 2019
First Posted: July 23, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
July 22, 2019
Last Update Posted: July 23, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Precision BioSciences, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This is a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and tolerability, find an appropriate dose to optimize safety and efficacy, and evaluate 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). Before initiating PBCAR20A, subjects will be administered lymphodepletion chemotherapy composed of fludarabine and cyclophosphamide. At Day 0 of the Treatment Period, subjects will receive a single intravenous (IV) infusion of PBCAR20A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of PBCAR20A will be followed in a separate long-term follow-up (LTFU) study for 15 years after exiting this study.
Detailed Description:
Open or close this module Conditions
Conditions: Non-Hodgkin's Lymphoma, Relapsed
Chronic Lymphoid Leukemia in Relapse
Non-Hodgkin's Lymphoma Refractory
Chronic Lymphocytic Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic
B-cell Chronic Lymphocytic Leukemia
B-cell Non Hodgkin Lymphoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 90 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PBCAR20A-01

In this study, PBCAR20A, allogeneic anti-CD20 CAR T Cells, is used to treat patients with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

Route of Administration: Intravenous infusion.

Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR20A infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.

Genetic: PBCAR20A
Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
Other Names:
  • Allogeneic Anti-CD20 CAR T cells
Drug: Fludarabine
Fludarabine is used for lymphodepletion.
Drug: Cyclophosphamide
Cyclophosphamide is used for lymphodepletion.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
2. 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.
Secondary Outcome Measures:
1. 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.
Other Outcome Measures:
1. Area Under the Curve [AUC]
[ Time Frame: 1 year ]

To evaluate Area Under the Curve [AUC] of PBCAR20A in patients tested.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Key Inclusion Criteria*

Criteria for NHL:

  • r/r 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 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 CLL/SLL:

  • Active CNS disease. A negative lumbar puncture is required at Screening if the study participant has a history of CNS disease.

Criteria for NHL and CLL/SLL:

  • 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.
  • Active hemolytic anemia.
  • 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 1 day prior to initiating lymphodepletion chemotherapy.
  • Received a systemic biologic agent within 30 days or 5 half-lives.
  • Received a live vaccine within 4 weeks before Screening.
  • Received standard cytotoxic chemotherapy within 10 days of 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.
    • Additional criteria apply
Open or close this module Contacts/Locations
Central Contact Person: Clinical Precision BioSciences, Inc.
Telephone: 919-314-5512
Email: clinical@precisionbiosciences.com
Study Officials: Chris Heery, MD
Study Chair
Chief Medical Officer
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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