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Relapsed/Refractory Multiple MyelomaPhase 1CaMMouflageNCT05722418

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

A Phase 1 study testing CB-011 in people with Relapsed/Refractory Multiple Myeloma, run by Caribou Biosciences, Inc. at 16 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
CB-011
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
16 sitesUnited States
Study dates
6 Feb 2023to Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
  • 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.
  • Eastern Cooperative Oncology Group performance status grade of 0 or 1.
  • Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.

Who cannot join

  • Prior treatment with CAR-T cell therapy directed at any target.
  • Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
  • Allogeneic stem cell transplant within 6 months before lymphodepletion.
  • Known active or prior history of CNS involvement.
  • Stroke or seizure within 6 months of signing ICF.
  • Seropositive for or history of human immunodeficiency virus.
Show all 10Show fewer
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
  • Hepatitis B infection.
  • Hepatitis C infection.
  • Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Caribou Biosciences contact

510-982-6030 ext. 3

clinicaltrials@cariboubio.com

16 sites in 1 country

United States16 sites, 16 recruiting

  • CU Anschutz Medical Campus, Anshutz Cancer Pavillion

    Aurora, Colorado, 80045

    Rona Wang, 303-724-2703, deng.wang@cuanschutz.edu

    Natalie Pfenning, 303-724-9562, natalie.pfenning@cuanschutz.edu

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Luciano Costa, MD, 205-975-3371, ljcosta@uabmc.edu

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Kelly Bumgarner, Kelly.Bumgarner@atriumhealth.org

    Manisha Bhutani, MD

    Recruiting

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45236

    Doug Hart, douglas.hart@usoncology.com

    James Essell, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    216-444-7923, Canceranswer@ccf.org

    Faiz Anwer, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Marcella Aguilar, Marcella.Aguilar@utsouthwestern.edu

    Larry Anderson, MD

    Recruiting

  • Duke University Health System (DUHS)

    Durham, North Carolina, 27705

    Matthew Fisher, 919-668-1028, Matthew.Fister@Duke.edu

    Cristina Gasparetto, MD

    Recruiting

  • Hackensack Meridian John Theurer Cancer Center

    Hackensack, New Jersey, 07601

    Oncology Clinical Research Referral Office, 551-996-1777, oncologyresearchreferral@hmhn.org

    David Siegal, MD

    Recruiting

  • University of Kentucky/ Markey Cancer Center

    Lexington, Kentucky, 40536

    Ashley Walton-Robbins, 589-218-1758, Ashley.robbins@uky.edu

    Gregory Monohan, MD

    Recruiting

  • Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

    Miami, Florida, 33136

    Jay Spiegel, MD, 305-243-0372, Spiegelj@med.miami.edu

    Jay Spiegel, MD

    Recruiting

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Danielle King, 414-805-9334, daking@mcw.edu

    Binod Dhakal, MD

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Jesus Berdeja, MD, 844-482-4812, jberdeja@tnonc.com

    Taylor Peach, 629-292-7183, tpeach@tnonc.com

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Adriana Rossi, MD, 917-828-3905, adriana.rossi@mssm.edu

    Adriana Rossi, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Sham Mailankody, MBBS, 646-608-2091, cart@mskcc.org

    Sham Mailankody, MBBS

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23235

    Johanna Biamonte, 804-628-1896, jbiamonte@vcu.edu

    William Clark, MD

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Collind Boyington, 801-587-4779, collind.boyington@HCI.UTAH.EDU

    Douglas Sborov, MD

    Recruiting

Other trials in United States

About this study

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)

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).

Being tested
CB-011
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
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CB-011Biological

    Also called Cyclophosphamide, Fludarabine

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

Study groups in NCT05722418
Study groupRoleWhat they receive
CB-011Experimental* 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
Receives: Biological: CB-011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (Part A) Number of patients with dose limiting toxicities (DLT)

    Number of patients with DLTs during the 28 days following the first administration of CB-011.

    Measured: 28 days

  2. (Part B) Overall Response Rate (ORR)

    The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start6 Feb 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05722418
Sponsor's protocol ID
CB11A
Acronym
CaMMouflage
Status last verified
Aug 2025
First submitted
19 Dec 2022
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CB-011 in people with Relapsed/Refractory Multiple Myeloma, run by Caribou Biosciences, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caribou Biosciences (510-982-6030 ext. 3, clinicaltrials@cariboubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(Part A) Number of patients with dose limiting toxicities (DLT) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05722418.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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