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Phase I, Open Label Dose-Escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCARTCS1A Administered in Patients with Relapsed/Refractory Multiple Myeloma

Clinical Trial Details

The purpose of this study is to determine the safety and tolerability of an experimental form of therapy called UCARTCS1A (sometimes referred to as the “study drug”). UCARTCS1A cells (allogeneic engineered T-cells expressing anti-CS1 chimeric antigen receptor) are special types of cells called T-cells that have been collected from a donor and then are genetically modified (changed). T-cells are related to your immune system, which helps to fight infection. The study doctor can describe how the study drug is designed to work.

UCARTCS1A is an investigational product. This means that UCARTCS1A is still being studied. It also means that the U.S. Food and Drug Administration (FDA) and other regulatory authorities do not allow it to be sold for treating patients. The regulatory authorities only allow UCARTCS1A to be used in research. This study is being done to look at:

  • How long it takes for the body to get rid of the UCARTCS1A
  • How much UCARTCS1A gets into the bloodstream
  • How much of the UCARTCS1A is safe and able to be tolerated
  • How well UCARTCS1A works for the treatment of multiple myeloma

There are 2 parts to the study: (1) dose escalation and (2) dose expansion.

The goal of the first part (Part 1) of this study is to test the safety and tolerability of up to 3 different doses of UCARTCS1A and to find the highest well-tolerated dose of UCARTCS1A that can be given to patients with multiple myeloma, including those who have relapsed (disease has come back) or whose disease is refractory (has not responded to treatment).

The goal of the second part of the study (Part 2), dose expansion, is to learn about the safety and efficacy of the dose of UCARTCS1A that was determined during part 1 of the study.

Key Eligibility: 

Inclusion Criteria

  • Patients with confirmed diagnosis of active multiple myeloma
  • Men and women 18-65 years of age
  • Ability and willingness to sign informed consent
  • Ability and willingness to comply with the study protocol procedures
  • Women of childbearing potential must have a negative highly sensitive serum pregnancy test performed within 7 days prior to enrollment

Exclusion Criteria

  • Previous treatment with investigational gene targeting CS1 or chimeric antigen receptor therapy targeting CS1
  • Prior treatment with a CS1-directed monoclonal antibody within 3 months before enrollment
  • Previous chemotherapy or biologic targeted therapy or immunological agents within 14 days prior to enrollment
  • Radioimmunotherapy or radiotherapy, within 8 weeks prior to enrollment and all along the study duration
  • Any cellular therapy (other than autologous or allogenic HSCT) within 60 days prior to enrollment
  • Prior allogeneic HSCT
  • Autologous hematopoietic stem cell transplantation (HSCT) within 12 weeks prior to enrollment

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
646-962-5060
ant9105@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1905020140

ClinicalTrials.gov:

NCT04142619

Sponsor:

UCARTCS1A_01

Status

Open to Enrollment

Age Group

Adult

Sponsor