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

Overview

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 one infusion of UCARTCS1A and to determine the Maximum Tolerated Dose (MTD).

On July 7, 2020, the FDA placed a clinical hold on this clinical trial based on a safety issue in one patient enrolled at the study at dose level two. Learn more

SparkCures ID 1038
Trial Phase Phase 1
Enrollment 18 Patients
Treatments
Tags
Trial Sponsors
  • Cellectis S.A.
NCT Identifier

NCT04142619

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • 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

US Trial Locations

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more


New Jersey
Verified John Theurer Cancer Center Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

New York
Texas

Resources

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