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)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Imugene Limited
Study ID
NCT03666000
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azer-cel — BIOLOGICAL
    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

Study Details

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.

Key Dates

First listed
Sep 11, 2018
Start date
Mar 11, 2019
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
135 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation: Azer-cel Dose Level 1
    Azer-cel, 3 x 10\^5 CAR T cells per kilogram (kg) body weight. Route of Administration: Intravenous infusion
  • Experimental: Phase 1 Dose Escalation: Azer-cel Dose Level 2
    Azer-cel, 1 x 10\^6 CAR T cells per kg body weight. Route of Administration: Intravenous infusion
  • Experimental: Phase 1 Dose Escalation: Azer-cel Dose Level 3a
    Azer-cel, 3 x 10\^6 CAR T cells per kg body weight. Route of Administration: Intravenous infusion
  • Experimental: Phase 1 Dose Escalation: Azer-cel Dose Level 4
    Azer-cel, 6 x 10\^6 CAR T cells per kg body weight as 2 administrations of 3 x 10\^6 CAR T cells per kg body weight on Day 0 and Day 10. Route of Administration: Intravenous infusion
  • Experimental: Phase 1 Dose Escalation: Azer-cel Dose Level 4b
    Azer-cel, 500 x 10\^6 CAR T cells (flat dose). Route of Administration: Intravenous infusion
  • Experimental: Phase 1B Dose Expansion: Azer-cel
    Azer-cel will be administered at a dose level established in Phase 1. Route of Administration: Intravenous infusion

Primary Outcome Measure

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 ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
City of HopeDuarteCalifornia91010-
H. Lee Moffitt Cancer CenterTampaFlorida33612
Clinical Research
Bijal Shah, MD (PRINCIPAL_INVESTIGATOR)
Northside Hospital Cancer InstituteAtlantaGeorgia30342
Clinical Trials
Scott Solomon, MD (PRINCIPAL_INVESTIGATOR)
Winship Cancer Institute Emory UniversityAtlantaGeorgia30322
Clinical Trials
Edmund Waller, MD (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Clinical Trials
Jean Yared, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Tufts Medical CenterBostonMassachusetts02111
Clinical Trials
Andreas Klein, MD (PRINCIPAL_INVESTIGATOR)
Barbara Ann Karmanos Cancer Institute (Wayne State University)DetroitMichigan48201-
University of MinnesotaMinneapolisMinnesota55455
Clinical Research
Supriya Gupta, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical Center/New York Presbyterian HospitalNew YorkNew York10032
Clinical Trials
Ran Reshef, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical College - NY Presbyterian HospitalNew YorkNew York10021-
Duke UniversityDurhamNorth Carolina27708-
Ohio State UniversityColumbusOhio43210-
Lifespan Cancer Institute at Rhode Island HospitalProvidenceRhode Island02903
Clinical Trials
Adam Olszewski, MD (PRINCIPAL_INVESTIGATOR)
Baylor University Medical CenterDallasTexas75246
Clinical Trials
Houston Holmes III, MD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030-
Medical College of WisconsinMilwaukeeWisconsin53226
Clinical Trials
Nirav Shah, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gilbert, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Banner MD Anderson Cancer Center· Gilbert, AZCity of Hope· Duarte, CAH. Lee Moffitt Cancer Center· Tampa, FLNorthside Hospital Cancer Institute· Atlanta, GAWinship Cancer Institute Emory University· Atlanta, GAUniversity of Maryland· Baltimore, MD

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