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)

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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorImugene Limited

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Azer-cel
Fludarabine
Cyclophosphamide
IL-2

Treatment groups

135 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Locations

Australia

Royal Prince Alfred Hospital2050, CamperdownNew South Wales, Australia

Liverpool Hospital2170, LiverpoolNew South Wales, Australia

Royal Adelaide Hospital5000, AdelaideSouth Australia, Australia

St Vincent's Hospital Melbourne3065, FitzroyVictoria, Australia

Sponsors and collaborators

Imugene Limited

Lead sponsor

Source ClinicalTrials.gov