Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With R… (NCT03666000) | Clinical Trial Compass
RecruitingPhase 1
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)
United States135 participantsStarted 2019-03-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria
Criteria for B-ALL:
• Participant has confirmed unequivocal r/r CD19+ B-ALL.
Criteria for NHL and CLL/SLL:
• Participant has unequivocal aggressive CD19+ r/r B-cell NHL that is confirmed by tumor biopsy tissue from last relapse after CD19-directed therapy.
For Phase 1 Dose Escalation:
* 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
For Phase 1b Dose Expansion (CAR T-relapsed cohort):
* DLBCL not otherwise specified (NOS)
* HGBCL
* DLBCL transformed from the following indolent lymphoma subtypes (FL, Marginal Zone lymphoma \[MZL\], and Waldenstrom's Macroglobulinemia \[WM\])
* Other large B-cell lymphoma (LBCL) subtypes may be enrolled with approval from the Medical Monitor.
* Participants previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product.
* For the expansion CAR T-relapsed cohort only: Participants must have received autologous CD19-directed CAR T therapy and demonstrated clinical response to the treatment at Day 28 or later, followed by relapse or progression.
For Phase 1b dose expansion (CAR T-naive cohort):
* DLBCL NOS
* DLBCL transformed from the following indolent lymphoma subtypes (FL, MZL, and WM)
* HGBCL
* FL (Grade 1-3a)
* MZL that is fluorodeoxyglucose (FDG)-avid on p…
What they're measuring
1
Phase 1 Dose Escalation/Phase 1b Dose Expansion: Number of Participants with Azer-cel-related AEs Defined as Dose-limiting Toxicities (DLTs)