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

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ClinicalTrials.gov Identifier: NCT04142619
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Cellectis S.A.

Tracking Information
First Submitted Date  ICMJE October 25, 2019
First Posted Date  ICMJE October 29, 2019
Last Update Posted Date September 23, 2021
Actual Study Start Date  ICMJE November 21, 2019
Estimated Primary Completion Date May 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2021)
Safety of UCARTCS1A [ Time Frame: 24 months. ]
Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
Safety of UCARTCS1A: Incidence, nature and severity of adverse events and serious adverse events (SAEs) [ Time Frame: 24 months. ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2021)
  • Response Assessment [ Time Frame: 24 months ]
    At Day 35, Day 56 (M2), Day 84 (M3), Follow-up [Q3M up to Month 24; i.e., Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24
  • Duration of Response [ Time Frame: 24 months ]
    Time Frame: From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24]
  • Progression Free Survival [ Time Frame: 24 months ]
    From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
  • Overall Survival [ Time Frame: 24 months ]
    From the first day of study treatment to the date of death from any cause, assessed up to Month 24
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01)
Official Title  ICMJE 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
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Multiple Myeloma
Intervention  ICMJE Biological: UCARTCS1A
Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor
Study Arms  ICMJE Experimental: Dose Escalation
Several tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified.
Intervention: Biological: UCARTCS1A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 28, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date May 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cellectis Central Contact 3475790635 clinicaltrials@cellectis.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04142619
Other Study ID Numbers  ICMJE UCARTCS1A_01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cellectis S.A.
Study Sponsor  ICMJE Cellectis S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cellectis S.A.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP