Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

Relapsed/Refractory Large B Cell Lymphoma Clinical Trial

— EXPAND  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05714345
• Other study ID #: ALLO-647-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 31, 2023
• Est. completion date: October 2029

Study information

• Verified date: May 2024
• Source: Allogene Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: October 2029
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Relapsed/Refractory Large B Cell Lymphoma

Intervention

Biological:
• ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Drug:
• Fludarabine
Chemotherapy for lymphodepletion
• Cyclophosphamide
Chemotherapy for lymphodepletion

Genetic:
• ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel
United States	University of Louisville James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Allogene Therapeutics

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Up to 60 months
Secondary	To assess the clinical efficacy of ALLO-647 as measured by Overall Response Rate (ORR) and assessed by IRC between treatment arms		Up to 60 months
Secondary	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		Up to 60 months
Secondary	To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by IRC between treatment arms		Up to 60 months
Secondary	To characterize the efficacy of ALLO-647 as measured by Progression Free Survival (PFS) and assessed by IRC between treatment arms		Up to 60 months
Secondary	To characterize the efficacy of ALLO-647 as measured by response rate per investigator review		Up to 60 months
Secondary	To characterize the efficacy of ALLO-647 as measured by DOR and assessed by investigator assessments between treatment arms		Up to 60 months
Secondary	To characterize the efficacy of ALLO-647 as measured by Overall Survival (OS)		Up to 60 months
Secondary	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		Up to 9 months
Secondary	To characterize the serum concentration of ALLO-647 as measured by microgram per microliter		Up to 10 days
Secondary	To characterize blood concentration of ALLO-501A when administered with lymphodepletion with and without ALLO-647 as measured by vector copy number		Up to 9 months
Secondary	To characterize the effects of ALLO-647 on host T cell concentrations as measured by T cell counts cells/microliter		Up to 9 months
Secondary	To evaluate the rate of anti-drug antibodies against ALLO-647 and ALLO-501A		Up to 9 months
Secondary	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		Up to 60 months
Secondary	To evaluate the incidence of treatment-emergent adverse events of ALLO-501A following lymphodepletion		Up to 60 months