Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma

Study Purpose

Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.

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

Inclusion Criteria:

  • - Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease.
  • - Documented measurable disease.
  • - Adequate organ function.
  • - Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1.

Exclusion Criteria:

  • - Plasma Cell Leukemia or History of Plasma Cell Leukemia.
  • - Patients with a history of severe hypersensitivity to DMSO should be excluded.
  • - Contraindication to fludarabine or cyclophosphamide.
  • - Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities.
- Active central nervous system disease involvement by malignancy or active CNS pathology

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.

NCT04155749
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.

Kite, A Gilead Company
Principal Investigator

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

Arcellx, Inc.
Principal Investigator Affiliation Arcellx, Inc.
Agency Class

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

Industry
Overall Status Recruiting
Countries United States
Conditions

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

Relapsed and Refractory Multiple Myeloma
Arms & Interventions

Arms

Experimental: ARM 1

Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma

Interventions

Drug: - anitocabtagene-autoleucel

Chimeric Antigen Receptor T cells

Drug: - ARC-T Plus Anti-BCMA SparX

Chimeric Antigen Receptor T cells plus SparX protein

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.

Chicago, Illinois

Status

Active, not recruiting

Address

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Daniella Cook

dtcook@partners.org

714-307-8479

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Site Contact

Emma Logan, BSN, RN, OCN

eklogan@bidmc.harvard.edu

617-667-5984

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Danielle Nissen

dnissen@mcw.edu

414-805-0581