Clinical Trials /

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

NCT04142619

Description:

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).

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: UCARTCS1A_01
  • NCT ID: NCT04142619

Conditions

  • Relapsed/Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
UCARTCS1ADose Escalation

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalSeveral tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified.
  • UCARTCS1A

Eligibility Criteria

        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
      
Maximum Eligible Age:64 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety of UCARTCS1A: Incidence, nature and severity of adverse events and serious adverse events (SAEs)
Time Frame:24 months.
Safety Issue:
Description:Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study. Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cellectis S.A.

Trial Keywords

  • Multiple Myeloma
  • Chimeric Antigen Receptor T-Cell (CART-T) therapy
  • Transcription Activator-Like Effector Nuclease (TALEN)
  • Allogeneic

Last Updated

November 26, 2019