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CC-98633

Phase 1

Multiple Myeloma | Monoclonal antibody | Oncology |cbdMD, Inc.|Last Updated: Jul 26, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

CC-98633 · 1 trial · 1 indication

Phase 1 1
NCT04394650A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple MyelomaMultiple Myeloma
COMPLETED78 Analytics
PHASE1COMPLETED
A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events (AEs)
From the time of informed consent and follow up to 2 years after infusion of CC-98633:

incidence and severity of AEs. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

Secondary Endpoints

Overall Response Rate (ORR)
Up to 2 years after CC-98633 infusion
Complete Response (CR) Rate
Up to 2 years after CC-99633 infusion
Duration of response (DOR)
Up to 2 years after CC-98633 infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CC-98633EXPERIMENTALSubjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).

Interventions

NameTypeDescription
CC-98633BIOLOGICALSubjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC-98633. During CC-98633 production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CC-98633 product, subjects will receive treatment with CC-98633 therapy. Study treatment will include lymphodepleting chemotherapy followed by one dose of CC-98633 administered by intravenous (IV) injection.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Age ≥ 18 years. 2. Signed written informed consent prior to any study procedure. 3. Relapsed and/or refractory multiple myeloma (MM). 1. Subjects must have documented progressive disease as per International Myeloma Working Group (IMWG) criteria during or within 12 months...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials

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 CC-98633

What is CC-98633 used for?

CC-98633 is an investigational monoclonal antibody being developed for the treatment of multiple myeloma. It is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy studied in participants with relapsed and/or refractory multiple myeloma. The drug is currently in Phase 1 clinical development.

What does CC-98633 target?

CC-98633 targets BCMA, which stands for B-cell maturation antigen. It is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy designed to recognize and attack cells expressing BCMA, which is commonly found on multiple myeloma cells. This targeting mechanism is central to its investigational use in treating multiple myeloma.

Who makes CC-98633?

CC-98633 is being developed by cbdMD, Inc., a company traded on the stock market under the ticker symbol YCBD. The company is conducting clinical research on this investigational therapy for multiple myeloma, with the drug currently in Phase 1 development.

What phase is CC-98633 in?

CC-98633 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial for CC-98633 has been completed, and the drug remains under investigation for multiple myeloma.

What clinical trials is CC-98633 in?

CC-98633 has one completed clinical trial registered under NCT04394650. This Phase 1 study, titled 'A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma,' enrolled 78 participants in the United States. The trial was uncontrolled and not randomized or double-blinded.

Is CC-98633 the same as BCMA-targeted CAR T cells?

CC-98633 is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy. The clinical trial NCT04394650 specifically describes CC-98633 as BCMA-targeted CAR T cells, indicating that CC-98633 is a form of CAR T cell therapy directed against BCMA for the treatment of multiple myeloma.