Multiple Myeloma Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

11

Study ID:

NCT04142619

Recruitment Status:

Terminated

Sponsor:

Cellectis S.A.

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There are 8 Locations for this study

See Locations Near You

UCSF Medical Center- Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Sarah Cannon Research Institute - Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Winship Cancer Institute Emory University
Atlanta Georgia, 30322, United States
Mayo Clinical Cancer Center (MCCC)
Rochester Minnesota, 55905, United States
Hackensack Meridian Health
Hackensack New Jersey, 07601, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Sarah Cannon Research Institute - Methodist Healthcare
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

11

Study ID:

NCT04142619

Recruitment Status:

Terminated

Sponsor:


Cellectis S.A.

How clear is this clinincal trial information?

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