Back to search results

Study of Azer-cel for Relapsed/Refractory Lymphoma and Leukemia

This study is testing a treatment called azer-cel (an allogeneic anti-CD19 CAR T cell therapy) for adults with certain types of blood cancers that have come back or not responded to previous treatments (relapsed/refractory). These include Non-Hodgkin Lymphoma (NHL), B-cell Acute Lymphoblastic Leukemia (B-ALL), and Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). Before receiving azer-cel, you will get other medications like fludarabine and cyclophosphamide. The main goals are to see how safe azer-cel is and to find the best dose, as well as to see how well it works in shrinking the cancer. We don't have information on the current recruitment status.

Study design
This is a Phase 1/1b study that is open-label, meaning everyone knows what treatment is being given. It is not randomized and plans to enroll 135 participants.
What's involved
Before receiving azer-cel, you will be given medications to prepare your body. You will then receive azer-cel through an IV, possibly followed by IL-2. You will be monitored for up to 720 days (about 2 years) or until your disease progresses.
Compensation
Not stated in the trial record.
Follow-up
All participants who receive azer-cel will be asked to join a separate long-term follow-up study for up to 15 years after this study ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03666000

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Imugene Limited
~135 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:Azer-celFludarabineCyclophosphamideIL-2

At a glance

Recruiting sites
15 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 Dose Escalation/Phase 1b Dose Expansion: Number of Participants with Azer-cel-related AEs Defined as Dose-limiting Toxicities (DLTs)
Measured over Up to Day 720
+2 more outcomes measured

Conditions

Non-Hodgkin Lymphoma
B-cell Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Explore related trials

B Acute Lymphoblastic LeukemiaChronic Lymphocytic LeukemiaNon-Hodgkin LymphomaPrimary Central Nervous System LymphomaSmall Lymphocytic LymphomaCD19 Gene

Where it's being run

23 sites across 17 states
Georgia2
Massachusetts2
New York2
Texas2
New South Wales2
Victoria2
Arizona1
California1

Study leadership

  • John Byon, MD, PhD · STUDY_CHAIR · Imugene Limited

Who to contact

Imugene Clinical Team
[email protected]
+1 984 245 0082
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
DLBCL not otherwise specified (NOS)
HGBCL
DLBCL transformed from the following indolent lymphoma subtypes (FL, Marginal Zone lymphoma \[MZL\], and Waldenstrom's Macroglobulinemia \[WM\])
Other large B-cell lymphoma (LBCL) subtypes may be enrolled with approval from the Medical Monitor.
Participants previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product.
For the expansion CAR T-relapsed cohort only: Participants must have received autologous CD19-directed CAR T therapy and demonstrated clinical response to the treatment at Day 28 or later, followed by relapse or progression.
DLBCL NOS
DLBCL transformed from the following indolent lymphoma subtypes (FL, MZL, and WM)
HGBCL
FL (Grade 1-3a)
MZL that is fluorodeoxyglucose (FDG)-avid on positron emission tomography (PET) scan
WM
CLL/SLL
Primary central nervous system (CNS) lymphoma (PCNSL)
Other LBCL subtypes may be enrolled with approval from the Medical Monitor.
Participant must have received at least 1-2 prior lines of therapy, depending on histological subtype but no more than 7 systemic lines of anti-cancer therapy.
Eastern Cooperative Oncology Group performance status score of 0 or 1.
An estimated life expectancy of at least 12 weeks according to the investigator's judgment.
Seronegative for human immunodeficiency virus antibody.
Participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.

Exclusion

Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression.
Active hemolytic anemia.
No active CNS disease, excluding PCNSL
History of another primary malignancy
Any form of primary immunodeficiency (for example, severe combined immunodeficiency disease).
History of hepatitis B or hepatitis C currently receiving ongoing antiviral therapy.
History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening.
History of severe immediate hypersensitivity reaction to any of the agents used in this study.
Presence of a CNS disorder that, in the opinion of the investigator, renders the participant ineligible for treatment.
History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or any other known bone marrow failure syndrome.
Active uncontrolled autoimmune disease requiring active immunosuppression at the time of Screening (excluding participants needing steroids for physiologic replacement).
Participant has received stem cell transplant within 90 days before Screening.
Participant has active graft-versus-host disease (GvHD) symptoms.
Participant has received a systemic biologic agent for treatment of the disease under study within 28 days of LD, other systemic anti-cancer therapy within 10 days or 5 half-lives (whichever is shorter) of LD, and no pulse steroid for disease control within 3 days of LD.
Radiotherapy within 4 weeks before Screening.
Presence of pleural/peritoneal/pericardial catheter, as well as permeant biliary and ureteral stents (does not apply to intravenous lines).
Participant has received live vaccine within 4 weeks before Screening. Note: Non-live virus vaccines are not excluded.
Participant has received CD19-directed therapy other than autologous CD19-directed CAR T therapy within 90 days of the anticipated start date of LD.

What this trial measures

  • Phase 1 Dose Escalation/Phase 1b Dose Expansion: Number of Participants with Azer-cel-related AEs Defined as Dose-limiting Toxicities (DLTs)Up to Day 720
  • Phase 1b Dose Expansion: Objective Response Rate (ORR) B-ALLUp to Day 720

    ORR for participants with B-ALL will be assessed by National Comprehensive Cancer Network (NCCN) 2017 criteria.

  • Phase 1b Dose Expansion: ORR NHLUp to Day 720

    ORR for participants with NHL will be assessed by Lugano classification, International Workgroup on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines, International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, and International Workshop on Waldenstrom's Macroglobulinemia (IWWM)-11 criteria.