Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2025-01-28

Brief Summary

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The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

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Detailed Description

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Conditions

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Relapsed/Refractory Large B Cell Lymphoma Relapsed/Refractory Follicular Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALLO-647, ALLO-501

Group Type EXPERIMENTAL

ALLO-501

Intervention Type GENETIC

ALLO-501 is an allogeneic CAR T cell therapy targeting CD19

ALLO-647

Intervention Type BIOLOGICAL

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Fludarabine

Intervention Type DRUG

Chemotherapy for lymphodepletion

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for lymphodepletion

Interventions

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ALLO-501

ALLO-501 is an allogeneic CAR T cell therapy targeting CD19

Intervention Type GENETIC

ALLO-647

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Intervention Type BIOLOGICAL

Fludarabine

Chemotherapy for lymphodepletion

Intervention Type DRUG

Cyclophosphamide

Chemotherapy for lymphodepletion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
* Relapse or refractory disease after at least 2 lines of chemotherapy
* At least 1 measurable lesion at time of screening.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate hematological, renal, liver, pulmonary, and cardiac functions.

Exclusion Criteria

* Current or history of central nervous system (CNS) lymphoma.
* Clinically significant CNS dysfunction.
* ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
* Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
* Systemic anticancer therapy within 2 weeks prior to study entry.
* On-going treatment with immunosuppressive agents.
* Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
* Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
* Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
* Patients unwilling to participate in an extended safety monitoring period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No