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CB-011

Phase 4

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

CB-011 development status

Highest phase Phase 4 run by Tongji Hospital (NCT05300932)
Phase scored for CRBUPhase 1
Registered trials 463+ across 166 sponsors since Nov 1999

CB-011 target and mechanism

Molecular targetBCMA
Target classProtein
ModalityMonoclonal antibody

Also known as Cyclophosphamide, Fludarabine

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

FAST_TRACKRMATORPHAN_DRUG

CB-011 clinical trials

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
Relapsed/Refractory Multiple MyelomaUnlock trial analytics

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 340 trials (matched to "Relapsed/Refractory Multiple Myeloma")

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.'