NCT04142619

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2019

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

3.6 years

First QC Date

October 25, 2019

Last Update Submit

September 21, 2023

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

Multiple MyelomaChimeric Antigen Receptor T-Cell (CART-T) therapyTranscription Activator-Like Effector Nuclease (TALEN)Allogeneic

Outcome Measures

Primary Outcomes (1)

  • Safety of UCARTCS1A

    Incidence, nature and severity of adverse events and serious adverse events (SAEs) throughout the study.

    24 months.

Secondary Outcomes (4)

  • Response Assessment

    24 months

  • Duration of Response

    24 months

  • Progression Free Survival

    24 months

  • Overall Survival

    24 months

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Several tested doses of UCARTCS1A until the Maximum Tolerated Dose (MTD) is identified.

Biological: UCARTCS1A

Interventions

UCARTCS1ABIOLOGICAL

Allogenic engineered T-cells expressing anti- CS1 Chimeric Antigen Receptor

Dose Escalation

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UCSF Medical Center- Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Sarah Cannon Research Institute - Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Winship Cancer Institute Emory University

Atlanta, Georgia, 30322, United States

Location

Mayo Clinical Cancer Center (MCCC)

Rochester, Minnesota, 55905, United States

Location

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

Sarah Cannon Research Institute - Tennessee Oncology

Nashville, Tennessee, 37203-1625, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Sarah Cannon Research Institute - Methodist Healthcare

San Antonio, Texas, 78229-6306, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

November 21, 2019

Primary Completion

June 18, 2023

Study Completion

June 18, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(8)