Health Trials

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 LymphomaB-cell Acute Lymphoblastic LeukemiaChronic Lymphocytic LeukemiaSmall 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

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Imugene Limited

Lead sponsor

Source ClinicalTrials.gov