Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01)

Relapsed/Refractory Multiple Myeloma Clinical Trial

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) Administered in Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04142619
• Other study ID #: UCARTCS1A_01
• Status: Terminated
• Phase: Phase 1
• Start date: November 21, 2019
• Est. completion date: June 18, 2023

Study information

• Verified date: September 2023
• Source: Cellectis S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 18, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

Biological:
• UCARTCS1A
Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor

Locations

Country	Name	City	State
United States	Winship Cancer Institute Emory University	Atlanta	Georgia
United States	Sarah Cannon Research Institute - Colorado Blood Cancer Institute	Denver	Colorado
United States	Hackensack Meridian Health	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute - Tennessee Oncology	Nashville	Tennessee
United States	Mayo Clinical Cancer Center (MCCC)	Rochester	Minnesota
United States	Sarah Cannon Research Institute - Methodist Healthcare	San Antonio	Texas
United States	UCSF Medical Center- Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Cellectis S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of UCARTCS1A	Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study.	24 months.
Secondary	Response Assessment	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	24 months
Secondary	Duration of Response	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]	24 months
Secondary	Progression Free Survival	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	24 months
Secondary	Overall Survival	From the first day of study treatment to the date of death from any cause, assessed up to Month 24	24 months