Actively Recruiting
Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
Led by Imugene Limited · Updated on 2026-02-02
135
Participants Needed
23
Research Sites
429 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r/r B ALL, r/r B-cell NHL and CLL/SLL.
CONDITIONS
Official Title
Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants with confirmed relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL)
- Participants with aggressive CD19-positive relapsed or refractory B-cell non-Hodgkin lymphoma confirmed by tumor biopsy after CD19-directed therapy
- For dose escalation: Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation, follicular lymphoma (FL) including Grade 3 or transformed FL, high-grade B-cell lymphoma (HGBCL), primary mediastinal lymphoma
- For dose expansion CAR T-relapsed cohort: DLBCL not otherwise specified (NOS), HGBCL, DLBCL transformed from indolent lymphoma subtypes (FL, marginal zone lymphoma, Waldenstrom's macroglobulinemia), other large B-cell lymphoma subtypes with approval
- Participants previously treated with CD19-directed autologous CAR T therapies with no more than 2 lines of therapy after previous CAR T
- For dose expansion CAR T-naive cohort: DLBCL NOS, transformed DLBCL, HGBCL, FL (Grade 1-3a), marginal zone lymphoma with positive PET scan, Waldenstrom's macroglobulinemia, CLL/SLL, primary central nervous system lymphoma, other large B-cell lymphoma subtypes with approval
- Participants must have received 1 to 7 prior lines of therapy depending on subtype
- Eastern Cooperative Oncology Group performance status score of 0 or 1
- Estimated life expectancy of at least 12 weeks
- Negative for human immunodeficiency virus antibody
- Adequate bone marrow, kidney, liver, lung, and heart function
You will not qualify if you...
- Burkitt cell (L3 ALL) or mixed-lineage acute leukemia
- Urgent need for therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
- Active hemolytic anemia
- Active central nervous system disease excluding primary central nervous system lymphoma
- History of another primary malignancy
- Any primary immunodeficiency such as severe combined immunodeficiency
- Current hepatitis B or C infection receiving antiviral treatment
- Uncontrolled cardiovascular disease
- History of hypertensive crisis or hypertensive encephalopathy within 3 months before screening
- Severe immediate hypersensitivity reaction to study agents
- Presence of central nervous system disorder making treatment unsuitable
- History of genetic bone marrow failure syndromes such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome
- Active uncontrolled autoimmune disease needing immunosuppression (except physiologic steroids)
- Stem cell transplant within 90 days before screening
- Active graft-versus-host disease symptoms
- Recent use of systemic biologic agents or anti-cancer therapy within specified timeframes before lymphodepletion
- Radiotherapy within 4 weeks before screening
- Presence of certain catheters or stents (excluding intravenous lines)
- Live vaccine within 4 weeks before screening
- CD19-directed therapy other than autologous CD19 CAR T within 90 days before lymphodepletion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Completed
2
City of Hope
Duarte, California, United States, 91010
Completed
3
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Winship Cancer Institute Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Northside Hospital Cancer Institute
Atlanta, Georgia, United States, 30342
Actively Recruiting
6
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
7
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Completed
9
Barbara Ann Karmanos Cancer Institute (Wayne State University)
Detroit, Michigan, United States, 48201
Completed
10
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
11
Weill Cornell Medical College - NY Presbyterian Hospital
New York, New York, United States, 10021
Completed
12
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
13
Duke University
Durham, North Carolina, United States, 27708
Completed
14
Ohio State University
Columbus, Ohio, United States, 43210
Completed
15
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
16
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
17
MD Anderson
Houston, Texas, United States, 77030
Completed
18
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
19
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
20
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
21
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
22
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
23
Barwon Health - Andrew Love Cancer Centre
Geelong, Victoria, Australia, 3320
Actively Recruiting
Research Team
I
Imugene Clinical Team
CONTACT
I
Imugene Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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