A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or Refractory Multiple Myeloma

Study Purpose

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX120 in subjects with relapsed or refractory multiple myeloma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Age ≥18 years. 2. Relapsed or refractory multiple myeloma, as defined by IMWG response criteria and treatment with at least 2 prior lines of therapy. 3. Eastern Cooperative Oncology Group performance status 0 or 1. 4. Adequate renal, liver, cardiac and pulmonary organ function. 5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX120 infusion. Key

Exclusion Criteria:

1. Prior allogeneic stem cell transplant (SCT). 2. Less than 60 days from autologous SCT at time of screening and with unresolved serious complications. 3. Prior treatment with any gene therapy or genetically modified cell therapy, including CAR T cells or natural killer cells, or BCMA-directed therapy. 4. Evidence of direct central nervous system (CNS) involvement by multiple myeloma. 5. History or presence of clinically relevant CNS pathology such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement. 6. Unstable angina, clinically significant arrhythmia, or myocardial infarction within 6 months of enrollment. 7. Active HIV, hepatitis B virus or hepatitis C virus infection. 8. Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years. 9. Use of systemic anti-tumor therapy or investigational agent within 14 days prior to enrollment. 10. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 11. Women who are pregnant or breastfeeding.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04244656
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

CRISPR Therapeutics AG
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ewelina Morawa, MD
Principal Investigator Affiliation CRISPR Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

The study may enroll approximately 80 subjects in total.

Arms & Interventions

Arms

Experimental: CTX120

Administered by IV infusion following lymphodepleting chemotherapy.

Interventions

Biological: - CTX120

CTX120 B-cell maturation antigen (BCMA)-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Chicago

Chicago, Illinois, 60637

Oregon Health and Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University

Portland, Oregon, 97239

Site Contact

Knight Navigators

navigators@ohsu.edu

+1 877-214-4634

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Sarah Cannon Research Institute, Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

International Sites

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Status

Recruiting

Address

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050

Site Contact

Christine Contacos

Christine.Contacos@health.nsw.gov.au

+1 877-214-4634

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Status

Recruiting

Address

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000

Toronto, Ontario, Canada

Status

Recruiting

Address

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X6

Badalona, Barcelona, Spain

Status

Recruiting

Address

Institut Catala d'Oncologia Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916

Universidad de Navarra, Pamplona, Navarra, Spain

Status

Recruiting

Address

Universidad de Navarra

Pamplona, Navarra, 31008

Site Contact

Maite San Miguel

eecc@unav.es

+1 877-214-4634

Hospital Universitario de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hospital Universitario de Salamanca

Salamanca, , 37007