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).
Recruiting
Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| UCARTCS1A | Dose Escalation |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Dose Escalation | Experimental | Several tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified. |
|
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 |
| 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 |
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Cellectis S.A. |
November 26, 2019
