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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 : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Cellectis S.A.

Study Description
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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 one infusion of UCARTCS1A and to determine the Maximum Tolerated Dose (MTD).

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Biological: UCARTCS1A Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 21, 2019
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
Several tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified.
 Biological: UCARTCS1A
Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142619


Contacts
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Contact: Cellectis Central Contact 3475790635 clinicaltrials@cellectis.com

Locations
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United States, Texas
MDACC Recruiting
Houston, Texas, United States, 77030
Contact: Krina Patel, Dr.         
Principal Investigator: Krina Patel         
Sponsors and Collaborators
Cellectis S.A.
More Information
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Responsible Party: Cellectis S.A.
ClinicalTrials.gov Identifier: NCT04142619     History of Changes
Other Study ID Numbers: UCARTCS1A_01
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cellectis S.A.:
Multiple Myeloma
Chimeric Antigen Receptor T-Cell (CART-T) therapy
Transcription Activator-Like Effector Nuclease (TALEN)
Allogeneic
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases