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Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies

Primary Purpose

CD19 Expressing Malignancies, Hematologic Malignancy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PBCAR19B
Sponsored by
Precision BioSciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CD19 Expressing Malignancies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Relapsed or refractory CD19+ expressing malignancies
  • At least 2 prior regimens per Standard of Care

Exclusion Criteria:

  • No history of active CNS involvement

Sites / Locations

  • Banner MDARecruiting
  • City of HopeRecruiting
  • Moffitt Cancer CenterRecruiting
  • Tufts Medical CenterRecruiting
  • Columbia UniversityRecruiting
  • Thomas Jefferson UniversityRecruiting
  • Lifespan Cancer Institute at Rhode Island HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Level 1

Dose Level 2

Dose Level 3

Arm Description

In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.

In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.

In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)
To determine the maximum tolerated dose (MTD)
Number of participants with Dose Limiting Toxicity(ies)
To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2020
Last Updated
November 8, 2022
Sponsor
Precision BioSciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04649112
Brief Title
Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies
Official Title
A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Precision BioSciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1, nonrandomized, open-label, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in adult study participants with CD-19 expressing malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD19 Expressing Malignancies, Hematologic Malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Level 1
Arm Type
Experimental
Arm Description
In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Description
In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.
Arm Title
Dose Level 3
Arm Type
Experimental
Arm Description
In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion.
Intervention Type
Genetic
Intervention Name(s)
PBCAR19B
Other Intervention Name(s)
Allogeneic Anti-CD19 CAR T cells
Intervention Description
Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Description
To determine the maximum tolerated dose (MTD)
Time Frame
Day 1 - Day 28
Title
Number of participants with Dose Limiting Toxicity(ies)
Description
To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Relapsed or refractory CD19+ expressing malignancies At least 2 prior regimens per Standard of Care Exclusion Criteria: No history of active CNS involvement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Precision BioSciences, Inc.
Phone
919-314-5512
Email
clinical@precisionbiosciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Vainorius, MD
Organizational Affiliation
Precision BioSciences, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Banner MDA
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajneesh Nath, MD
First Name & Middle Initial & Last Name & Degree
Rajneesh Nath, MD
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Herrera, MD
First Name & Middle Initial & Last Name & Degree
Alex Herrera, MD
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Jain, MD
First Name & Middle Initial & Last Name & Degree
Michael Jain, MD
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Klein, MD
First Name & Middle Initial & Last Name & Degree
Andreas Klein, MD
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Reshef, MD
First Name & Middle Initial & Last Name & Degree
Ran Reshef, MD
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Usama Gergis, MD
First Name & Middle Initial & Last Name & Degree
Usama Gergis, MD
Facility Name
Lifespan Cancer Institute at Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Olszewski, MD
First Name & Middle Initial & Last Name & Degree
Adam Olszewski, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies

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