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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05000450
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Allogene Therapeutics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Genetic: ALLO-605 Biological: ALLO-647 Drug: Fludarabine Drug: Cyclophosphamide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : June 6, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALLO-605, ALLO-647 Genetic: ALLO-605
ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product

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

Drug: Fludarabine
Chemotherapy for lymphodepletion

Drug: Cyclophosphamide
Chemotherapy for lymphodepletion


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-605 that will determine MTD/MAD and select the recommended Phase 2 dose (RP2D) of ALLO-605. [ Time Frame: 28 days ]
    Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion

  2. Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605] [ Time Frame: 30 days ]
    Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 30 days following 1st infusion

  3. Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR) [ Time Frame: 12 months of study follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05000450


Contacts
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Contact: Allogene 415-650-0034 clinicaltrials@allogene.com

Locations
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United States, Colorado
Sarah Cannon/Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Katherine Bertolin    720-754-4419      
Contact       katherine.bertolin@sarahcannon.com   
United States, Texas
St. David's South Austin Medical Center Recruiting
Austin, Texas, United States, 78704
Contact: Renee Stojanovic, BSN    512-816-6423    renee.stojanovic@stdavids.com   
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Texas Transplant Institute Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Allogene Therapeutics
More Information
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Responsible Party: Allogene Therapeutics
ClinicalTrials.gov Identifier: NCT05000450    
Other Study ID Numbers: ALLO-605-201
IGNITE Study ( Other Identifier: Allogene )
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allogene Therapeutics:
CAR T
Cell Therapy
Allogeneic Cell Therapy
Cellular Immuno-therapy
 AlloCAR T
ALLO-605
ALLO-647
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists