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

A

Allogene Therapeutics

Status and phase

Active, not recruiting
Phase 1

Conditions

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

Treatments

Drug: Fludarabine
Drug: Cyclophosphamide
Genetic: ALLO-501
Biological: ALLO-647

Study type

Interventional

Funder types

Industry

Identifiers

NCT03939026
ALLO-501-201

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

74 participants in 1 patient group

ALLO-647, ALLO-501
Experimental group
Treatment:
Biological: ALLO-647
Genetic: ALLO-501
Drug: Cyclophosphamide
Drug: Fludarabine

Trial contacts and locations

7

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems