Clinical trial NCT05722418: CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Official title: A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed/Refractory Multiple Myeloma
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
Lead sponsor: Caribou Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).


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.

Primary outcomes:
measure: (Part A) Number of patients with dose limiting toxicities (DLT)
timeFrame: 28 days
measure: (Part B) Overall Response Rate (ORR)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Aurora
country: United States
facility: CU Anschutz Medical Campus, Anshutz Cancer Pavillion
state: Colorado
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
state: Florida
city: Lexington
country: United States
facility: University of Kentucky/ Markey Cancer Center
state: Kentucky
city: Hackensack
country: United States
facility: Hackensack Meridian John Theurer Cancer Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System (DUHS)
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute, University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert and the Medical College of Wisconsin
state: Wisconsin
Study officials:
References: