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TerminatedNCT04142619Updated Sep 22, 2023

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

A Phase 1 interventional study of UCARTCS1A in Relapsed/Refractory Multiple Myeloma, sponsored by Cellectis S.A.. Terminated at 8 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Cellectis S.A. · Phase 1, Interventional, and Treatment

Why this study was terminated
The trial was discontinued due to sponsor's decision and not a consequence of any safety concern.

From the registry’s dates

  • Primary completion was Jun 2023, 3 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study 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).

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Conditions studied

  • Relapsed/Refractory Multiple Myeloma

Keywords

  • Multiple Myeloma
  • Chimeric Antigen Receptor T-Cell (CART-T) therapy
  • Transcription Activator-Like Effector Nuclease (TALEN)
  • Allogeneic
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 11 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Cellectis S.A. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Dose Escalation

    Several tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified.

    Biological: UCARTCS1A

Interventions

  • BiologicalUCARTCS1A

    Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor

06

What researchers measure

Primary outcomes

  1. Safety of UCARTCS1A

    Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study.

    Time frame: 24 months.

Secondary outcomes

  1. Response Assessment

    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

    Time frame: 24 months

  2. Duration of Response

    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\]

    Time frame: 24 months

  3. Progression Free Survival

    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

    Time frame: 24 months

  4. Overall Survival

    From the first day of study treatment to the date of death from any cause, assessed up to Month 24

    Time frame: 24 months

07

Study locations

8 sites
  • 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 37203-1625, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Sarah Cannon Research Institute - Methodist Healthcare
    San Antonio, Texas 78229-6306, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04142619
Lead sponsor
Cellectis S.A.
Responsible party
Sponsor
First posted
Oct 29, 2019
Start date
Nov 21, 2019
Primary completion
Jun 18, 2023
Completion
Jun 18, 2023
Last update
Sep 22, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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