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

Primary Purpose

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

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALLO-501
ALLO-647
Fludarabine
Cyclophosphamide
Sponsored by
Allogene Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Large B Cell Lymphoma focused on measuring CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501, ALLO-647, LBCL, Lymphoma, Follicular Lymphoma, Large B-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Banner MD Anderson Cancer Center
  • University of California, Los Angeles
  • Stanford University
  • Colorado Blood Cancer Institute
  • Moffitt Cancer Center
  • Norton Cancer Institute
  • St. Davids South Austin Medical Center
  • MD Anderson

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALLO-647, ALLO-501

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion

Secondary Outcome Measures

Full Information

First Posted
April 4, 2019
Last Updated
May 25, 2022
Sponsor
Allogene Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03939026
Brief Title
Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
Acronym
ALPHA
Official Title
A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allogene Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma
Keywords
CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-501, ALLO-647, LBCL, Lymphoma, Follicular Lymphoma, Large B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALLO-647, ALLO-501
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
ALLO-501
Intervention Description
ALLO-501 is an allogeneic CAR T cell therapy targeting CD19
Intervention Type
Biological
Intervention Name(s)
ALLO-647
Intervention Description
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Chemotherapy for lymphodepletion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Chemotherapy for lymphodepletion
Primary Outcome Measure Information:
Title
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
Description
Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
Time Frame
28 days
Title
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
Description
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
Time Frame
33 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
St. Davids South Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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