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Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01)

Cancer Type
Multiple Myeloma
Trial Phase
Phase I
18 - 64 Years, Male and Female
Study Type
Protocol IDs
UCARTCS1A_01 (primary)
Study Sponsor
Cellectis S.A.


This is a Phase I, FIH, open-label, dose escalation study evaluating Safety and Efficacy
of UCART targeting CS1 in patients with Relapsed or Refractory Multiple Myeloma (MM). The
purpose of this study is to evaluate the safety and clinical activity of UCARTCS1A and to
determine the Maximum Tolerated Dose (MTD).


  1. Patients with confirmed diagnosis of active multiple myeloma (as defined by International Myeloma Working Group [IMWG] criteria) who have relapsed/refractory disease after and have received at least 3 prior lines of prior therapy.
  2. Eastern Cooperative Oncology Group Performance Status of 0 or 1;
  3. No previous treatment with investigational gene targeting CS1 or chimeric antigen receptor therapy targeting CS1
  4. Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within the screening period.
  5. Other criteria may apply.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.