Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

NCT ID: NCT05000450

Last Updated: 2024-06-28

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

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-06

Study Completion Date

2023-10-11

Brief Summary

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The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Detailed Description

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Conditions

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Relapsed/Refractory Multiple Myeloma

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-605, ALLO-647

Group Type EXPERIMENTAL

ALLO-605

Intervention Type GENETIC

ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product

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-605

ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product

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

* Documented diagnosis of relapsed/refractory multiple myeloma (MM)
* Subjects must have measurable disease
* Subjects must have received ≥3 prior MM lines of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal, liver, pulmonary, and cardiac functions
* Life expectancy of at least 3 months without treatment

Exclusion Criteria

* Subjects with known active or history of central nervous system (CNS) or leptomeningeal involvement of myeloma or plasma cell leukemia
* Current or history of thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
* Autologous stem cell transplantation within last 6 weeks prior to the start of lymphodepletion
* Any prior allogeneic hematopoietic stem cell transplantation
* Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allogene Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sarah Cannon/Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

St. David's South Austin Medical Center

Austin, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Texas Transplant Institute

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IGNITE Study

Identifier Type: OTHER

Identifier Source: secondary_id

ALLO-605-201

Identifier Type: -

Identifier Source: org_study_id

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