Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04142619 |
Recruitment Status :
Recruiting
First Posted : October 29, 2019
Last Update Posted : November 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Relapsed/Refractory Multiple Myeloma | Biological: UCARTCS1A | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Allocation: | N/A |
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 |
Actual Study Start Date : | November 21, 2019 |
Estimated Primary Completion Date : | November 1, 2022 |
Estimated Study Completion Date : | November 1, 2022 |

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

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | 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 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

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
Contact: Cellectis Central Contact | 3475790635 | clinicaltrials@cellectis.com |
United States, New Jersey | |
Hackensack Meridian Health | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Cellectis Central Contact | |
United States, New York | |
Weill Cornell Medical College | Recruiting |
New York, New York, United States, 10065 | |
Contact: Cellectis Central Contact | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Krina Patel, Dr. | |
Principal Investigator: Krina Patel |
Responsible Party: | Cellectis S.A. |
ClinicalTrials.gov Identifier: | NCT04142619 |
Other Study ID Numbers: |
UCARTCS1A_01 |
First Posted: | October 29, 2019 Key Record Dates |
Last Update Posted: | November 20, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Chimeric Antigen Receptor T-Cell (CART-T) therapy Transcription Activator-Like Effector Nuclease (TALEN) Allogeneic |
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 |