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

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ClinicalTrials.gov Identifier: NCT05714345

Recruitment Status : Recruiting

First Posted : February 6, 2023

Last Update Posted : December 14, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Allogene Therapeutics

Tracking Information

First Submitted Date ^ICMJE

December 8, 2022

First Posted Date ^ICMJE

February 6, 2023

Last Update Posted Date

December 14, 2023

Actual Study Start Date ^ICMJE

March 31, 2023

Estimated Primary Completion Date

April 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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) [ Time Frame: Up to 60 months ]

Original Primary Outcome Measures ^ICMJE

To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by progression free survival and assessed by IRC in subjects with R/R LBCL [ Time Frame: Up to 60 months ]

Change History

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To assess the clinical efficacy of ALLO-647 as measured by ORR and assessed by IRC between treatment arms [ Time Frame: Up to 60 months ]
To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by EFS and assessed by IRC in subjects with R/R LBCL [ Time Frame: Up to 60 months ]
To characterize the efficacy of ALLO-647 as measured by DOR and assessed by IRC between treatment arms [ Time Frame: Up to 60 months ]
To characterize the efficacy of ALLO-647 as measured by PFS and assessed by IRC between treatment arms [ Time Frame: Up to 60 months ]
To characterize the efficacy of ALLO-647 as measured by response rate per investigator review [ Time Frame: Up to 60 months ]
To characterize the efficacy of ALLO-647 as measured by DOR and assessed by investigator assessments between treatment arms [ Time Frame: Up to 60 months ]
To characterize the efficacy of ALLO-647 as measured by overall survival [ Time Frame: Up to 60 months ]
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 [ Time Frame: Up to 9 months ]
To characterize the serum concentration of ALLO-647 as measured by microgram per microliter [ Time Frame: Up to 10 days ]
To characterize blood concentration of ALLO-501A when administered with lymphodepletion with and without ALLO-647 as measured by vector copy number [ Time Frame: Up to 9 months ]
To characterize the effects of ALLO-647 on host T cell concentrations as measured by T cell counts cells/microliter [ Time Frame: Up to 9 months ]
To evaluate the rate of anti-drug antibodies against ALLO-647 and ALLO-501A [ Time Frame: Up to 9 months ]
To evaluate the incidence of treatment-emergent adverse events of ALLO-647 by comparing FCA lymphodepletion with FC lymphodepletion [ Time Frame: Up to 60 months ]
To evaluate the incidence of treatment-emergent adverse events of ALLO-501A following lymphodepletion [ Time Frame: Up to 60 months ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Relapsed/Refractory Large B Cell Lymphoma

Intervention ^ICMJE

Biological: ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Drug: Fludarabine
Chemotherapy for lymphodepletion
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion
Genetic: ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19

Study Arms ^ICMJE

Experimental: Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
Interventions:
- Biological: ALLO-647
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Genetic: ALLO-501A
Experimental: Lymphodepletion with fludarabine and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
Interventions:
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Genetic: ALLO-501A

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

October 2029

Estimated Primary Completion Date

April 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Allogene Therapeutics

415-604-5696

clinicaltrials@allogene.com

Listed Location Countries ^ICMJE

Austria, Belgium, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05714345

Other Study ID Numbers ^ICMJE

ALLO-647-201

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Allogene Therapeutics

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Allogene Therapeutics

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Allogene Therapeutics

Verification Date

December 2023

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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