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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)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Azer-cel

    Biological/Vaccine

    Infusion of Allogeneic Anti-CD19 CAR T cells

  • Fludarabine

    Drug

    Specified dose on specified days

  • Cyclophosphamide

    Drug

    Specified dose on specified days

  • IL-2

    Drug

    Specified dose on specified days

  • Ibrutinib, Acalabrutinib, Zanubrutinib, or Pirtobrutinib

    Drug

    Specified dose on specified days

Treatment groups

135 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Phase 1 Dose Escalation: Azer-cel Dose Level 1Experimental treatment 3 interventions
Group B: Phase 1 Dose Escalation: Azer-cel Dose Level 2Experimental treatment 3 interventions
Group C: Phase 1 Dose Escalation: Azer-cel Dose Level 3aExperimental treatment 3 interventions
Group D: Phase 1 Dose Escalation: Azer-cel Dose Level 4Experimental treatment 3 interventions
Group E: Phase 1 Dose Escalation: Azer-cel Dose Level 4bExperimental treatment 3 interventions
Group F: Phase 1B Dose Expansion: Azer-celExperimental treatment 4 interventions
Group G: Phase 1B Dose Expansion: Azer-cel + Bruton's tyrosine kinase inhibitorExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Phase 1 Dose Escalation/Phase 1b Dose Expansion: Number of Participants with Azer-cel-related AEs Defined as Dose-limiting Toxicities (DLTs)

Time frame
Up to Day 720
2

Phase 1b Dose Expansion: Objective Response Rate (ORR) B-ALL

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

Time frame
Up to Day 720
3

Phase 1b Dose Expansion: ORR NHL

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.

Time frame
Up to Day 720

Secondary outcomes

1

Phase 1 Dose Escalation: ORR

* B-ALL: NCCN 2017 criteria * NHL: Lugano classification

Time frame
Up to Day 720
2

Complete Response (CR) Rate

* B-ALL: NCCN 2017 criteria * NHL: Lugano classification

Time frame
Up to day 720
3

Duration of Response (DoR)

\- Defined as the duration (days) from initial response to disease progression or death.

Time frame
Up to day 720
4

Progression-free survival (PFS)

\- Defined as the duration (days) from Day 0 to disease progression or death.

Time frame
Up to day 720

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imugene Limited

Lead sponsor

Source ClinicalTrials.gov
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