CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Caribou Biosciences, Inc.
Study ID
NCT05722418
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CB-011 — BIOLOGICAL
    CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion

Study Details

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).

Key Dates

Start date
Feb 6, 2023
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CB-011
    * Part A Escalation with CB-011 in ascending doses using a traditional 3+3 design. * Part B Expansion. Up to 30 participants will be enrolled to receive CB-011 at the RDE/MTD and/or RP2D determined in Plan A

Primary Outcome Measure

(Part A) Number of patients with dose limiting toxicities (DLT) [ Time Frame: 28 days ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Luciano Costa, MD
[email protected]
205-975-3371
CU Anschutz Medical Campus, Anshutz Cancer PavillionAuroraColorado80045
Rona Wang
[email protected]
303-724-2703
Natalie Pfenning
[email protected]
303-724-9562
Daniel Sherbenou, MD, PhD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer Center, University of Miami Hospital and ClinicsMiamiFlorida33136
Jay Spiegel, MD
[email protected]
305-243-0372
Jay Spiegel, MD (PRINCIPAL_INVESTIGATOR)
University of Kentucky/ Markey Cancer CenterLexingtonKentucky40536
Ashley Walton-Robbins
[email protected]
589-218-1758
Gregory Monohan, MD (PRINCIPAL_INVESTIGATOR)
Hackensack Meridian John Theurer Cancer CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
David Siegal, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Adriana Rossi, MD
[email protected]
917-828-3905
Adriana Rossi, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Sham Mailankody, MBBS
[email protected]
646-608-2091
Sham Mailankody, MBBS (PRINCIPAL_INVESTIGATOR)
Levine Cancer InstituteCharlotteNorth Carolina28204
Kelly Bumgarner
[email protected]
Manisha Bhutani, MD (PRINCIPAL_INVESTIGATOR)
Duke University Health System (DUHS)DurhamNorth Carolina27705
Matthew Fisher
[email protected]
919-668-1028
Cristina Gasparetto, MD (PRINCIPAL_INVESTIGATOR)
Oncology Hematology Care, IncCincinnatiOhio45236
James Essell, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
[email protected]
216-444-7923
Faiz Anwer, MD (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203
Jesus Berdeja, MD
[email protected]
844-482-4812
Taylor Peach
[email protected]
629-292-7183
Jesus Berdeja, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Marcella Aguilar
[email protected]
Larry Anderson, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112
Collind Boyington
[email protected]
801-587-4779
Douglas Sborov, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23235
Johanna Biamonte
[email protected]
804-628-1896
William Clark, MD (PRINCIPAL_INVESTIGATOR)
Froedtert and the Medical College of WisconsinMilwaukeeWisconsin53226
Danielle King
[email protected]
414-805-9334
Binod Dhakal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Alabama at Birmingham· Birmingham, ALCU Anschutz Medical Campus, Anshutz Cancer Pavillion· Aurora, COSylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics· Miami, FLUniversity of Kentucky/ Markey Cancer Center· Lexington, KYHackensack Meridian John Theurer Cancer Center· Hackensack, NJIcahn School of Medicine at Mount Sinai· New York, NY

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