Experimental drug combo targets tough blood cancers
NCT ID NCT01905813
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a new drug called INCB040093, alone or combined with itacitinib, in 121 adults with B-cell cancers that had come back or stopped responding to treatment. The main goal was to find safe doses and check for side effects. Researchers also looked for signs that the drugs might shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INCB040093 (a PI3Kδ inhibitor) and itacitinib (a JAK1 inhibitor)
- What this could lead to
- If it works, this could point toward a new treatment option for people with B-cell cancers that have not responded to prior therapies.
- What could go wrong
- This is an early Phase 1 trial focused on safety and dosing, not on proving effectiveness. The drug may cause side effects or fail to shrink tumors in later studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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121 people
The number who actually took part.
- Started
-
Jun 2013
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: • Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows: \*Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma: EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma INCLUDING: any non-Hodgkin's B-cell malignancy such as CLL and rare non-Hodgkin's B-cell subtypes such as Hairy Cell Leukemia, Waldenstrom macroglobulinemia, Mantle cell lymphoma, transformed NHL histologies, etc. \*Hodgkin's lymphoma * Life expectancy of 12 weeks or longer. * Subject must have received ≥ 1 prior treatment regimen. * The subject must not be a candidate for potentially curative therapy, including stem cell transplant. Exclusion Criteria: * Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug. * Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent). * Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy. * Has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3. * Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant. * Received autologous hematopoietic stem cell transplant within the last 3 months. * Laboratory parameters not within the protocol-defined range. * Current or recent history (\<30 days prior to screening and/or \<45 days prior to dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial infection. * Current clinically active viral infection. * Known history of infection with the human immunodeficiency virus (HIV). * History of active hepatitis or positive serology for hepatitis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Study site
Birmingham, Alabama, United States
-
Study site
Jacksonville, Florida, United States
-
Study site
Ann Arbor, Michigan, United States
-
Study site
Rochester, Minnesota, United States
-
Study site
New York, New York, United States
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Study site
Rochester, New York, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Patient's own t cells engineered to hunt lymphoma in early trial
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Two-Drug combo targets tough Non-Hodgkin's lymphoma
- Triple drug combo targets mantle cell lymphoma