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Cobomarsen

Phase 1

Cutaneous T-cell Lymphoma (CTCL) | Small molecule | Oncology |CASI Pharmaceuticals, Inc.|Last Updated: Nov 23, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

Cobomarsen · 1 trial · 5 indications

Phase 1 1
NCT02580552Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLLCutaneous T-cell Lymphoma (CTCL)
COMPLETED66 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL
Cutaneous T-cell Lymphoma (CTCL)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of cobomarsen based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events
From start of treatment to end of study participation

Secondary Endpoints

Area under the plasma concentration vs. time curve (AUC) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Up to 56 days
Peak plasma concentration (Cmax) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Up to 56 days
Trough plasma concentration (Ctrough) of cobomarsen following each 4-week cycle of dosing
Monthly from Week 5 up to end of study participation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A, MFEXPERIMENTALIntratumoral Injection of cobomarsen
Part B, MFEXPERIMENTALSubcutaneous, intravenous or a combination of systemic and intratumoral administration of cobomarsen with or without stable background therapy
Part C, MFEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part D, CLLEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part E, DLBCL, activated B-cell (ABC) subtypeEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part F, ATLLEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy

Interventions

NameTypeDescription
CobomarsenDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Parts A-C only: Patients must have biopsy proven MF, clinical stage I, II, or III (excluding visceral or nodal involvement), and must be refractory to or intolerant of established therapies for their condition * Part D only: Patients diagnosed with CLL who are intolerant to, o...

Countries:United States
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Competitive Landscape -Cutaneous T-Cell Lymphoma 3 trials (matched to "Cutaneous T-cell Lymphoma (CTCL)")

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Frequently asked questions about Cobomarsen

What is Cobomarsen used for?

Cobomarsen is an investigational small molecule being developed for Cutaneous T-cell Lymphoma (CTCL), a type of non-Hodgkin lymphoma that affects the skin. It is also being studied in related blood cancers including Mycosis Fungoides, Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, and Adult T-Cell Leukemia/Lymphoma.

Who makes Cobomarsen?

Cobomarsen is being developed by CASI Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CASI. The company is conducting clinical research on this investigational oncology drug candidate.

What phase is Cobomarsen in?

Cobomarsen is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 clinical trial has been completed, and the drug remains in early-stage clinical development for Cutaneous T-cell Lymphoma and related conditions.

What clinical trials is Cobomarsen in?

Cobomarsen has one completed clinical trial registered as NCT02580552, titled "Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL." This Phase 1 study enrolled 66 participants in the United States and included patients with Cutaneous T-cell Lymphoma and other blood cancers.

Is Cobomarsen the same as MRG-106?

Yes, Cobomarsen is also known as MRG-106. The clinical trial NCT02580552 used the name MRG-106 in its title, and this alternative name refers to the same investigational drug candidate being developed by CASI Pharmaceuticals.