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MDX-1342

Phase 1

Chronic Lymphocytic Leukemia | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: May 22, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

MDX-1342 · 2 trials · 2 indications

Phase 1 2
NCT00593944Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia
COMPLETED15 Analytics
NCT00639834Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED26 Analytics
PHASE1COMPLETED
Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic LeukemiaUnlock trial analytics
PHASE1COMPLETED
Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

incidence and severity of treatment-emergent adverse events
all events will be followed to resolution

Secondary Endpoints

response
12 weeks
clinical laboratory tests
study duratation - each visit
physical examination
study duration - each visit
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPatients will receive active MDX-1342.

Interventions

NameTypeDescription
MDX-1342BIOLOGICALMDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * relapsed/refractory CD19-positive CLL * At least 28 days since prior treatment for CLL * ECOG PS 0-2 * Screening laboratory values must be met Exclusion Criteria: * No prior anti-CD19 antibody tx * No active, uncontrolled infection * No prior allogeneic bone marrow transplan...

Countries:United StatesGermanyHungaryUkraineUnited Kingdom
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Frequently asked questions about MDX-1342

What is MDX-1342 used for?

MDX-1342 is an investigational monoclonal antibody being studied for rheumatoid arthritis and chronic lymphocytic leukemia. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being developed by Bristol-Myers Squibb Company.

What does MDX-1342 target?

MDX-1342 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being investigated for its potential role in treating rheumatoid arthritis and chronic lymphocytic leukemia.

Who makes MDX-1342?

MDX-1342 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with rheumatoid arthritis and chronic lymphocytic leukemia.

What phase is MDX-1342 in?

MDX-1342 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to assess its safety and potential efficacy in treating rheumatoid arthritis and chronic lymphocytic leukemia.

What clinical trials is MDX-1342 in?

MDX-1342 has been studied in two completed Phase 1 trials. NCT00593944 evaluated the drug in 15 patients with chronic lymphocytic leukemia in the United States. NCT00639834 studied MDX-1342 in combination with methotrexate in 26 patients with rheumatoid arthritis across multiple countries.

Is MDX-1342 the same as any other drug?

No alternative names for MDX-1342 have been disclosed. The drug is identified solely by its code name MDX-1342 in clinical trial registries and is being developed by Bristol-Myers Squibb Company.