Relapsed/Refractory Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Chimeric Antigen Receptor T-Cell (CART-T) therapy, Transcription Activator-Like Effector Nuclease (TALEN), Allogeneic
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 UCARTCS1A and to determine the Maximum Tolerated Dose (MTD).
Interventions
BIOLOGICALUCARTCS1A
Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor
Sponsors
Cellectis S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of UCARTCS1A | 24 months. | Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Assessment | 24 months | At Day 35, Day 56 (M2), Day 84 (M3), Follow-up \[Q3M up to Month 24; i.e., Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24 |
| Duration of Response | 24 months | Time Frame: From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24\] |
| Progression Free Survival | 24 months | 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 |
| Overall Survival | 24 months | From the first day of study treatment to the date of death from any cause, assessed up to Month 24 |
Countries
United States
Outcome results
None listed