Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)

Overview

About this study

The purpose of this research study is to find out if the experimental treatment, ALLO-715 in combination with ALLO-647, is safe and effective in treating multiple myeloma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (serum, urine, or free light chain [FLC]) per International Myeloma Working Group (IMWG) 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:

  • Current or history of Central Nervous System (CNS) involvement of myeloma or plasma cell leukemia.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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Jacksonville, Fla.

Mayo Clinic principal investigator

Sikander Ailawadhi, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20484366

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