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

Status
Completed
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 - 64 Years, Male and Female
Study Type
Treatment
NCT ID
NCT04142619
Protocol IDs
UCARTCS1A_01 (primary)
NCI-2019-07562
Study Sponsor
Cellectis S.A.

Summary

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).

Eligibility

  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
404-778-5180
winshipcancer.emory.edu

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