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CB-011

Phase 1

Relapsed/Refractory Multiple Myeloma | Monoclonal antibody | Oncology |Caribou Biosciences, Inc.|Last Updated: Sep 25, 2025

Target and mechanism

Molecular targetBCMA
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

FAST_TRACKRMATORPHAN_DRUG

Clinical trial landscape

CB-011 · 1 trial · 1 indication

Phase 1 1
NCT05722418CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple MyelomaRelapsed/Refractory Multiple Myeloma
RECRUITING50 Analytics
PHASE1RECRUITING
CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
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Study Endpoints

Primary Endpoints

(Part A) Number of patients with dose limiting toxicities (DLT)
28 days

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

(Part B) Overall Response Rate (ORR)
12 Months

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

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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

Interventions

NameTypeDescription
CB-011BIOLOGICALCB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

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 a...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials (matched to "Relapsed/Refractory Multiple Myeloma")

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about CB-011

What is CB-011 used for in Relapsed/Refractory Multiple Myeloma?

CB-011 is an investigational CRISPR-edited allogeneic anti-BCMA CAR-T cell therapy being developed for the treatment of relapsed/refractory multiple myeloma. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does CB-011 target?

CB-011 targets BCMA, a protein expressed on multiple myeloma cells. It is a CRISPR-edited allogeneic CAR-T cell therapy designed to recognize and attack BCMA-positive tumor cells.

Who makes CB-011?

CB-011 is being developed by Caribou Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CRBU.

What phase is CB-011 in?

CB-011 is currently in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The FDA has granted it Fast Track, Regenerative Medicine Advanced Therapy (RMAT), and Orphan Drug designations.

What clinical trials is CB-011 in?

CB-011 is being evaluated in a Phase 1 clinical trial with the identifier NCT05722418. This trial is recruiting patients with relapsed/refractory multiple myeloma in the United States and has an estimated enrollment of 50 participants.

Is CB-011 the same as a CRISPR-edited allogeneic anti-BCMA CAR-T cell therapy?

Yes, CB-011 is a CRISPR-edited allogeneic anti-BCMA CAR-T cell therapy. It is being studied in patients with relapsed/refractory multiple myeloma, and the ongoing clinical trial is titled 'CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma.'