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

Stopped early · Phase 1

Conditions studied: Relapsed/Refractory Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT04142619

Run by

Cellectis S.A.

People needed

11

Starts

2019-11-21

Expected to finish

2023-06-18

Last updated by the study team

2023-09-22

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• Previous treatment with investigational gene therapy targeting CS1 or chimeric antigen receptor therapy targeting CS1;
• Any cellular therapy (other than autologous or allogenic HSCT) within 60 days prior to enrollment;
• Prior treatment with rituximab or other anti-CD20 therapy within 3 months
• Any known active or uncontrolled infection
• Autologous hematopoietic stem cell transplantation (HSCT) within 12 weeks prior to enrollment; any cellular therapy (other than autologous) within 60 days prior to enrollment; prior allogeneic HSCT.
• Seropositive for Hepatitis C virus or positive for Hepatitis B surface antigen or core antibody.
• Presence of active and clinically relevant central nervous system disorder, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.

Where it is running

• UCSF Medical Center- Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Sarah Cannon Research Institute - Colorado Blood Cancer Institute — Denver, Colorado, United States
• Winship Cancer Institute Emory University — Atlanta, Georgia, United States
• Mayo Clinical Cancer Center (MCCC) — Rochester, Minnesota, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States
• Sarah Cannon Research Institute - Tennessee Oncology — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Sarah Cannon Research Institute - Methodist Healthcare — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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