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

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ClinicalTrials.gov Identifier: NCT03939026

Recruitment Status : Active, not recruiting

First Posted : May 6, 2019

Last Update Posted : May 26, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Allogene Therapeutics

Tracking Information

First Submitted Date ^ICMJE

April 4, 2019

First Posted Date ^ICMJE

May 6, 2019

Last Update Posted Date

May 26, 2022

Actual Study Start Date ^ICMJE

May 1, 2019

Estimated Primary Completion Date

December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501 [ Time Frame: 28 days ]
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 [ Time Frame: 33 days ]
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion

Original Primary Outcome Measures ^ICMJE

Phase 1: Proportion of patients experiencing Dose Limiting Toxicities at increasing doses of ALLO-501 [ Time Frame: 28 days ]
Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
Phase 1: Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501 [ Time Frame: 33 days ]
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
Phase 2: Overall Response Rate [ Time Frame: Up to 9 months ]

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Phase 1 and 2: Incidence and severity of adverse events with ALLO-501 and ALLO-647 in combination with fludarabine/cyclophosphamide [ Time Frame: Up to 9 months ]
Phase 1 and 2: Cellular kinetics of ALLO-501 [ Time Frame: Up to 9 months ]
Levels of Anti-CD19 CAR T Cells in Blood
Phase 1 and 2: Pharmacokinetics of ALLO-647 [ Time Frame: Up to 9 months ]
Serum concentration levels of ALLO-647
Phase 1 and 2: Incidence of immunogenicity against ALLO-501 and ALLO-647 [ Time Frame: Up to 9 months ]
Phase 1 and 2: Immune monitoring after lymphodepletion regimen [ Time Frame: Up to 9 months ]
Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells
Phase 1: Overall Response Rate [ Time Frame: Up to 9 months ]
Phase 1 and 2: Duration of response [ Time Frame: Up to 9 months ]
Phase 1 and 2: Progression-free survival [ Time Frame: Up to 9 months ]
Phase 1 and 2: Time to Response [ Time Frame: Up to 9 months ]
Phase 1 and 2: Overall survival [ Time Frame: Up to 9 months ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

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

Study Arms ^ICMJE

Experimental: ALLO-647, ALLO-501

Interventions:

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

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Estimated Study Completion Date ^ICMJE

August 2026

Estimated Primary Completion Date

December 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03939026

Other Study ID Numbers ^ICMJE

ALLO-501-201

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

May 2022

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

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