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).
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
Drug | Synonyms | Arms |
---|
UCARTCS1A | | Dose 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
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Several tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified. | |
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