Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
NCT ID: NCT04093596
Last Updated: 2023-08-14
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE1
132 participants
INTERVENTIONAL
2019-09-23
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ALLO-647, ALLO-715, Nirogacestat
ALLO-715
ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
Nirogacestat
a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.
Interventions
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ALLO-715
ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
Nirogacestat
a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.
Eligibility Criteria
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Inclusion Criteria
* At least 3 prior lines of MM therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody (unless contraindicated), and refractory to the last treatment line.
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Absence of donor (product)-specific anti-HLA antibodies
* Adequate hematologic, renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria
* Clinically significant CNS disorder
* Current or history of thyroid disorder
* Autologous stem cell transplant within the last 6 weeks, or any allogeneic stem cell transplant
* Prior treatment with anti-BCMA therapy, any gene therapy, any genetically modified cell therapy, or adoptive T cell therapy
* History of HIV infection or acute or chronic active hepatitis B or C infection
* Patients unwilling to participate in an extended safety monitoring period
* Inability to swallow tablets
* Subject has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
* Use of strong/moderate CYP3A4 inhibitors, and strong CYP3A4 inducers within 14 days before starting nirogacestat.
* Use of concomitant medications that are known to prolong the QT/QTcF interval
18 Years
ALL
No
Sponsors
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Allogene Therapeutics
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Sarah Cannon/Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Mailankody S, Matous JV, Chhabra S, Liedtke M, Sidana S, Oluwole OO, Malik S, Nath R, Anwer F, Cruz JC, Htut M, Karski EE, Lovelace W, Dillon M, Butz E, Ying W, Balakumaran A, Kumar SK. Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results. Nat Med. 2023 Feb;29(2):422-429. doi: 10.1038/s41591-022-02182-7. Epub 2023 Jan 23.
Abba Moussa D, Vazquez M, Chable-Bessia C, Roux-Portalez V, Tamagnini E, Pedotti M, Simonelli L, Ngo G, Souchard M, Lyonnais S, Chentouf M, Gros N, Marsile-Medun S, Dinter H, Pugniere M, Martineau P, Varani L, Juan M, Calderon H, Naranjo-Gomez M, Pelegrin M. Discovery of a pan anti-SARS-CoV-2 monoclonal antibody with highly efficient infected cell killing capacity for novel immunotherapeutic approaches. Emerg Microbes Infect. 2025 Dec;14(1):2432345. doi: 10.1080/22221751.2024.2432345. Epub 2024 Dec 9.
Other Identifiers
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ALLO-715-101
Identifier Type: -
Identifier Source: org_study_id
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