Clinical trial NCT05714345: Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
Official title: A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Relapsed/Refractory Large B Cell Lymphoma
Keywords: CAR T
Cell Therapy
Allogeneic Cell Therapy
Cellular Immuno-therapy
AlloCAR T
ALLO-501A
ALLO-647
LBCL
Lymphoma
Large B-Cell Lymphoma
Lead sponsor: Allogene Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse
* Relapsed or refractory disease after at least 2 lines of chemotherapy
* ECOG performance status 0 or 1
* Absence of significant donor (product)-specific anti-HLA antibodies (DSA)
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Active central nervous system involvement by malignancy
* Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
* Hypocellular bone marrow for age

Primary outcomes:
measure: To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by IRC in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma)
timeFrame: Up to 60 months
Secondary outcomes:
measure: To assess the clinical efficacy of ALLO-647 as measured by Overall Response Rate (ORR) and assessed by IRC between treatment arms
timeFrame: Up to 60 months
measure: To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by Event-Free Survival (EFS) and assessed by IRC in subjects with R/R LBCL
timeFrame: Up to 60 months
measure: To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by IRC between treatment arms
timeFrame: Up to 60 months
measure: To characterize the efficacy of ALLO-647 as measured by Progression Free Survival (PFS) and assessed by IRC between treatment arms
timeFrame: Up to 60 months
measure: To characterize the efficacy of ALLO-647 as measured by response rate per investigator review
timeFrame: Up to 60 months
measure: To characterize the efficacy of ALLO-647 as measured by DOR and assessed by investigator assessments between treatment arms
timeFrame: Up to 60 months
measure: To characterize the efficacy of ALLO-647 as measured by Overall Survival (OS)
timeFrame: Up to 60 months
measure: To characterize lymphodepletion with and without ALLO-647 as measured by absolute lymphocyte count/microliter; T cell counts/microliter; B cell counts/microliter, NK cell counts/microliter
timeFrame: Up to 9 months
measure: To characterize the serum concentration of ALLO-647 as measured by microgram per microliter
timeFrame: Up to 10 days
measure: To characterize blood concentration of ALLO-501A when administered with lymphodepletion with and without ALLO-647 as measured by vector copy number
timeFrame: Up to 9 months
measure: To characterize the effects of ALLO-647 on host T cell concentrations as measured by T cell counts cells/microliter
timeFrame: Up to 9 months
measure: To evaluate the rate of anti-drug antibodies against ALLO-647 and ALLO-501A
timeFrame: Up to 9 months
measure: To evaluate the incidence of treatment-emergent adverse events of ALLO-647 by comparing ALLO-647, fludarabine, and cyclophosphamide (FCA) lymphodepletion with fludarabine and cyclophosphamide (FC) lymphodepletion
timeFrame: Up to 60 months
measure: To evaluate the incidence of treatment-emergent adverse events of ALLO-501A following lymphodepletion
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville James Graham Brown Cancer Center
state: Kentucky
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References: