Clinical Trial

Disease: B-cell Acute Lymphoblastic Leukaemia, B-ALL, (NCT03666000)

Disease info:

Leukaemia is cancer of the white blood cells which are responsible for fighting infection. In leukaemia, the bone marrow produces abnormal levels of white blood cells. B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive (fast-growing) type of leukaemia in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. It is the most common type of ALL. Also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia.

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.

 

 

Frequency:
ALL accounts for less than 1% of all cancers in the U.S., with around 6,540 new cases estimated in the U.S. in 2023. ALL is the most common type of cancer found in children, though it can affect adults too.
Official title:
Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
Who:

Contact

Imugene Clinical Team

Phone: 984-245-0082

Email: info@imugene.com 

Sponsor:

Imugene Limited

Partners:
Locations:

United States, Arizona

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

 

United States, California

City of Hope, Duarte, California, United States, 91010

 

United States, Florida

H. Lee Moffitt Cancer Center, Tampa, Florida, United States, 33612

 

United States, Georgia

Winship Cancer Institute Emory University, Atlanta, Georgia, United States, 30322

Northside Hospital Cancer Institute, Atlanta, Georgia, United States, 30342   

 

United States, Massachusetts

Tufts Medical Center, Boston, Massachusetts, United States, 02111

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

 

United States, Michigan

Barbara Ann Karmanos Cancer Institute (Wayne State University), Detroit, Michigan, United States, 48201

 

United States, Minnesota

University of Minnesota, Minneapolis, Minnesota, United States, 55455

 

United States, New York

Weill Cornell Medical College - NY Presbyterian HospitalR, New York, New York, United States, 10021

Columbia University Irving Medical Center/New York Presbyterian Hospital, New York, New York, United States, 10032

 

United States, North Carolina

Duke University, Durham, North Carolina, United States, 27708

 

United States, Rhode Island

Lifespan Cancer Institute at Rhode Island Hospital, Providence, Rhode Island, United States, 02903

 

United States, Texas

Baylor University Medical Center, Dallas, Texas, United States, 75246

MD Anderson, Houston, Texas, United States, 77030

Study start:
Mar. 11, 2019
Enrollment:
120 participants
Gene editing method:
Meganucleases
Type of edit:
Gene knock-out, gene knock-in
Gene:
T-cell Receptor Alpha Constant (TRAC), CD19 molecule
Delivery method:
- Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT03666000
Safety updates:

(12-02-2024) Precision BioSciences Receives Initial $7.5 Million Cash Payment and Equity Investment from TG Therapeutics for Azel-Cel in Treatment of Autoimmune Diseases

(15-08-2023) Precision BioSciences Completes Strategic Transaction with Imugene for Azer-Cel in Cancer

(09-01-2024) Precision BioSciences Completes License Deal with TG Therapeutics for Cell Therapy Azer-Cel in Treatment of Autoimmune Diseases

(08-06-2022) Precision BioSciences Provides Update on Allogeneic CAR T Programs and Path Forward with Its Lead PBCAR0191 Candidate for CAR T Relapsed Patient Population

 

Other links:

LinkB-cell Acute Lymphoblastic Leukemia Disease InformationLinkB-cell Acute Lymphoblastic Leukemia FrequencyLinkPrecision Biosciences Allogeneic CAR TLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem QasimLinkLatest Gene Editing Clinical Trials for Cancer

Note:
PBCAR0191 is an allogeneic 'off-the-shelf' CAR T therapy. Using T cells derived from healthy donors as starting material, then utilizes the ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a cell product that is designed to prevent graft-versus-host disease.
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR0191 in adults with r/r B ALL (Cohort A) and in adults with r/r B-cell NHL (Cohort N).

Before initiating PBCAR0191, subjects will be administered lymphodepletion chemotherapy composed of fludarabine and cyclophosphamide. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of PBCAR0191. Subjects who receive a split dose will also receive an IV infusion of PBCAR0191 on Day 10 and/or Day 14. Subjects may be considered for retreatment. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of PBCAR0191 will be followed in a separate long-term follow-up (LTFU) study for 15 years after exiting this study.

Intervention:

  • Genetic: PBCAR0191

    Single dose of Allogeneic Anti-CD19 CAR T cells will be infused

    Other Name: Allogeneic Anti-CD19 CAR T cells

  • Drug: Fludarabine

    Fludarabine is used for lymphodepletion.

  • Drug: Cyclophosphamide

    Cyclophosphamide is used for lymphodepletion.

Last updated: Mar. 8, 2024
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