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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)

NCT03666000 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-02-02

No results posted yet for this study

Summary

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

Interventions

BIOLOGICAL

Azer-cel

Infusion of Allogeneic Anti-CD19 CAR T cells

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

DRUG

IL-2

Specified dose on specified days

Sponsors & Collaborators

  • Imugene Limited

    lead INDUSTRY

Principal Investigators

  • John Byon, MD, PhD · Imugene Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03666000 on ClinicalTrials.gov