A Study Evaluating the Safety and Effectiveness of UCART Targeting CS1 in Patients with Relapsed/Refractory Multiple Myeloma (MELANI-01)


About this study

The purpose of this study is to evaluate the safety and clinical activity of one infusion of UCARTCS1A (t-cells) and to determine the Maximum Tolerated Dose (MTD).

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:

  • Patients between the ages of 18-64 years old.
  • Patients with confirmed diagnosis of active multiple myeloma (as defined by International Myeloma Working Group [IMWG] criteria) who have relapsed after prior lines of therapy.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • No previous treatment with investigational gene targeting CS1 or chimeric antigen receptor therapy targeting CS1.
  • Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within the screening period.
  • Other criteria may apply.

Exclusion Criteria:

  • Individuals under 18 and over 64 years of age.

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

Rahma Warsame, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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