Trial Title:
CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT05722418
Condition:
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Cyclophosphamide
Fludarabine
Conditions: Keywords:
CaMMouflage
Allogeneic
Multiple Myeloma
Relapse Refractory Multiple Myeloma
CAR-T Cells
BCMA
Cell Therapy
Cellular Immuno-therapy
CB11A
CB-011
CB-011A
CAR-T
Anti BCMA
ALLO CAR T
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CB-011
Description:
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for
lymphodepletion Fludarabine Chemotherapy for lymphodepletion
Arm group label:
CB-011
Other name:
Cyclophosphamide
Other name:
Fludarabine
Summary:
This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an
allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell
maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the
effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or
that is no longer responding to other treatment (refractory).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable
disease (according to IMWG diagnostic criteria.)
2. Received at least 3 prior MM treatment lines of therapy which must include a
proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38
monoclonal antibody as part of a prior line of therapy, either in monotherapy or in
combination.
3. Eastern Cooperative Oncology Group performance status grade of 0 or 1.
4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
Exclusion Criteria:
1. Prior treatment with CAR-T cell therapy directed at any target.
2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
3. Allogeneic stem cell transplant within 6 months before lymphodepletion.
4. Known active or prior history of CNS involvement.
5. Stroke or seizure within 6 months of signing ICF.
6. Seropositive for or history of human immunodeficiency virus.
7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
8. Hepatitis B infection.
9. Hepatitis C infection.
10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its
excipients.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luciano Costa, MD
Phone:
205-975-3371
Email:
ljcosta@uabmc.edu
Facility:
Name:
CU Anschutz Medical Campus, Anshutz Cancer Pavillion
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rona Wang
Phone:
303-724-2703
Email:
deng.wang@cuanschutz.edu
Contact backup:
Last name:
Natalie Pfenning
Phone:
303-724-9562
Email:
natalie.pfenning@cuanschutz.edu
Investigator:
Last name:
Daniel Sherbenou, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jay Spiegel, MD
Phone:
305-243-0372
Email:
Spiegelj@med.miami.edu
Investigator:
Last name:
Jay Spiegel, MD
Email:
Principal Investigator
Facility:
Name:
University of Kentucky/ Markey Cancer Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Walton-Robbins
Phone:
589-218-1758
Email:
Ashley.robbins@uky.edu
Investigator:
Last name:
Gregory Monohan, MD
Email:
Principal Investigator
Facility:
Name:
Massachusetts General
Address:
City:
Boston
Zip:
220071
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Branagan, MD
Phone:
617-724-4000
Email:
abranagan@mgh.harvard.edu
Investigator:
Last name:
Andrew Branagan, MD
Email:
Principal Investigator
Facility:
Name:
John Theurer Cancer Center at Hackensack UMC
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Palka Anand
Phone:
551-996-8704
Email:
Palka.anand@hmhn.org
Investigator:
Last name:
David Siegal, MD
Email:
Principal Investigator
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adriana Rossi, MD
Phone:
917-828-3905
Email:
adriana.rossi@mssm.edu
Investigator:
Last name:
Adriana Rossi, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sham Mailankody, MBBS
Phone:
646-608-2091
Email:
cart@mskcc.org
Investigator:
Last name:
Sham Mailankody, MBBS
Email:
Principal Investigator
Facility:
Name:
Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelly Bumgarner
Email:
Kelly.Bumgarner@atriumhealth.org
Investigator:
Last name:
Manisha Bhutani, MD
Email:
Principal Investigator
Facility:
Name:
Duke University Health System (DUHS)
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Fisher
Phone:
919-668-1028
Email:
Matthew.Fister@Duke.edu
Investigator:
Last name:
Cristina Gasparetto, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Hematology Care, Inc
Address:
City:
Cincinnati
Zip:
45236
Country:
United States
Status:
Recruiting
Contact:
Last name:
Doug Hart
Email:
douglas.hart@usoncology.com
Investigator:
Last name:
James Essell, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Phone:
216-444-7923
Email:
Canceranswer@ccf.org
Investigator:
Last name:
Faiz Anwer, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marcella Aguilar
Email:
Marcella.Aguilar@utsouthwestern.edu
Investigator:
Last name:
Larry Anderson, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shiny Jayan
Phone:
832-438-7390
Email:
sjayan@mdanderson.org
Investigator:
Last name:
Neeraj Saini, MD
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Collind Boyington
Phone:
801-587-4779
Email:
collind.boyington@HCI.UTAH.EDU
Investigator:
Last name:
Douglas Sborov, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Johanna Biamonte
Phone:
804-628-1896
Email:
jbiamonte@vcu.edu
Investigator:
Last name:
William Clark, MD
Email:
Principal Investigator
Facility:
Name:
Froedtert and the Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle King
Phone:
414-805-9334
Email:
daking@mcw.edu
Investigator:
Last name:
Binod Dhakal, MD
Email:
Principal Investigator
Start date:
February 6, 2023
Completion date:
February 2027
Lead sponsor:
Agency:
Caribou Biosciences, Inc.
Agency class:
Industry
Source:
Caribou Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05722418
