Summary

Eligibility
for people ages 18-64 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Nina Shah
Photo of Nina Shah
Nina Shah

Description

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).

Official Title

Phase I, Open-label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCARTCS1A (Allogenic Engineered T-cells Expressing Anti-CS1 Chimeric Antigen Receptor) Administered in Patients With Relapsed/Refractory Multiple Myeloma

Keywords

Relapsed/Refractory Multiple Myeloma Multiple Myeloma Chimeric Antigen Receptor T-Cell (CART-T) therapy Transcription Activator-Like Effector Nuclease (TALEN) Allogeneic Neoplasms, Plasma Cell UCARTCS1A Dose Escalation

Eligibility

You can join if…

Open to people ages 18-64

  • 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 CAN'T join 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.

Locations

  • UCSF Medical Center- Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Lead Scientist at UCSF

  • Nina Shah
    Professor, Medicine. Authored (or co-authored) 119 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cellectis S.A.
ID
NCT04142619
Phase
Phase 1
Study Type
Interventional
Last Updated