Common Variable Immunodeficiency (CVID)Phase 2NCT06897358
Leniolisib for Immune Dysregulation in CVID
A Phase 2 study testing Leniolisib in people with Common Variable Immunodeficiency (CVID), run by Pharming Technologies B.V. at 7 sites in 3 countries.
Trial summary
In this study, common variable immunodeficiency (CVID) patients will all receive the study drug, leniolisib, for a treatment period of 6 months. Participants will start on a lower dose of leniolisib, followed by a mid and then a higher dose level. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Common Variable Immunodeficiency (CVID)
- What is being tested?
- Leniolisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 12 Feb 2025to 12 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is 12 to 75 years of age (inclusive).
- Specifically at sites located in the United Kingdom subjects must be 18 to 75 years of age (inclusive)
- Subject must have a minimum body weight of 45 kg
- Subject has a clinical diagnosis of CVID supported by all of the following (a thru c):
- A low IgG level compared to age-adjusted reference range [OR if this cannot be documented, subject must have one of the following: i) absent isohemagglutinins and/or poor response to vaccines; or ii) Low class-switched memory B cells less than 2%]
- Low IgA and/or IgM compared to age-adjusted reference range
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- No identified secondary causes of hypogammaglobulinemia
- Inborn Errors of Immunity/ PID Panel testing:
- Lacks an identified pathogenic/likely pathogenic genetic driver for their CVID primary immunodeficiency OR
- Subject has an identified pathogenic/likely pathogenic genetic driver(s) for their CVID limited to the following genes: TNFRSF13B (TACI), TNFRSF13C (BAFFR), CD19, CD20, CD81, CR2 (CD21), LRBA, CTLA4, NFKB1, NFKB2, IKZF1 (excluding variants associated with combined immune deficiency), CARD11 (gain of function), SH3KBP1, SEC61A1 IRF2BP2, CTNNBL1, TWEAK or PTEN.
- Subject has lymphoproliferation, as evidenced by CT imaging: splenomegaly with craniocaudal spleen measurement >10 cm and/or lymphadenopathy with at least 1 measurable index lymph node (long axis >1.5 cm) as per Cheson methodology.
- Subject has at least ONE of the following CVID clinical manifestations of immune dysregulation:
- Clinical symptoms related to splenomegaly or lymphadenopathy which interfere with activities of daily living or are associated with chronic pain, dyspnea, functional impairment, or limitations in usual activities
- One or more blood cytopenias related to CVID (and not due to other medical conditions such as iron-deficiency or lead exposure) defined as hemoglobin <10 g/dL, platelet count <100,000/µL, and/or neutrophil count <1,000/µL
- Previous pathologic confirmation of ILD and attributed to CVID by the Investigator with quantifiable CT chest imaging findings evident on baseline CT scan
- Clinical diagnosis of CVID enteropathy or other GI tract diagnosis attributable to CVID by the Investigator which involves the small intestine and meets the following enteropathy criteria:
- Clinical symptoms of GI disease including at least 1 of: abdominal pain or diarrhea at least 3 days of the week for at least 4 weeks or longer, or dependence on supplemental enteral or parenteral nutrition ii. Lacks a clinical diagnosis of Celiac Disease, and negative human leukocyte antigen (HLA)-DQ2 and -DQ8 testing at screening iii. Presence of small bowel villous shortening/atrophy/blunting with or without intraepithelial lymphocytosis noted in a pathology report pertaining to a small bowel biopsy performed within 5 years of enrollment iv. Negative stool PCR Gastrointestinal Profile at screening
- At screening, vital signs. Ranges:
- Systolic blood pressure 80-159 mm Hg Diastolic blood pressure 50-109 mm Hg Pulse rate 50-110 beats per minute (bpm) Oxygen saturation 93-100%
- Subjects or their legal representatives (for subjects under the age of 18 years) must be able to communicate with the Investigator and understand and comply with the requirements of the study, including an ability to provide written informed consent.
Who cannot join
- Laboratory evidence of significant T cell deficiency including CD4+ T cells <200/uL.
- Laboratory evidence of significant NK cell deficiency including NK cells <1% of peripheral blood lymphocytes or less than 50/mcL.
- Clinical history of infections suggestive of clinically significant T cell or NK cell deficiency such as Pneumocystis jirovecii, atypical mycobacteria, severe warts, or unusually severe (as determined by the PI) infections with herpesviruses.
- Presence of uncontrolled chronic/recurrent infectious disease (except those considered to be characteristic of antibody deficiency).
- Positive blood polymerase chain reaction (PCR) for cytomegalovirus.
- Evidence of tuberculosis infection
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- Positive blood cryptococcal antigen
- Previous or concurrent use of immunosuppressive medication, such as:
- Use of an mTOR inhibitor or a PI3K inhibitor within 3 weeks.
- Rituximab or other B cell depleting antibodies, belimumab, cyclophosphamide, or alemtuzumab within 6 months.
- Cyclosporine A, mycophenolate mofetil, 6-mercaptopurine, azathioprine, methotrexate, tacrolimus, ruxolitinib, or other Janus kinase (JAK) inhibitors within 3 weeks.
- Glucocorticoids above 25 mg prednisone or equivalent per day within 2 weeks
- Immunosuppressive monoclonal or polyclonal antibody therapeutics such as directed against TNF-alpha, α₄β₇ integrin, IL-6, IL-12/IL-23 and others within 5 half-lives
- Other immunosuppressive agents expected to have a significant impact on immune cell number or function.
- Abatacept is allowed during study if the subject has been receiving a stable dosing regimen for more than 3 months .
- Enteral budesonide is allowed during study if the subject has been receiving a stable dosing regimen for more than 3 months.
- Subject is receiving concurrent treatment with another investigational therapy or use of another investigational therapy less than 4 weeks or 5 half-lives (whichever is longer).
- HIstory of hypersensitivity to the study drug or to drugs of similar chemical classes.
- Current use of medication known to be a strong inhibitor, or moderate or strong inducer, of isoenzyme cytochrome P450 CYP3A.
- Current use of medications that, to a larger extent, are BCRP, OATP1B1, and/or OATP1B3 substrates.
- History of HIV or positive test result at screening.
- Any surgical or medical condition which may jeopardize the subject in case of participation in the study.
- Chronic need for supplemental oxygen or invasive or non-invasive respiratory support.
- Liver failure or clinically significant liver disease or dysfunction as indicated by alanine transaminase (ALT) or aspartate transaminase (AST) greater than 2.5 times the upper limit of normal, bilirubin greater than 1.5 times the upper limit of normal, international normalized ratio (INR) greater than 1.5 in the absence of anticoagulation, or presence of diuretic refractory ascites.
- Elevation of ALT or AST up to 6 times the upper limit of normal is allowed if elevation is determined to be a consequence of immune dysregulation by the site Principal Investigator and if the elevation has been stable for 3 months prior to enrollment.
- History of significant renal injury/renal disease severely affecting renal function or presence of impaired renal function as indicated by estimated glomerular filtration rate of less than 30 mL/min/1.73 m2.
- A positive hepatitis B surface antigen (HBsAg), positive hepatitis B PCR, positive hepatitis C PCR, or positive hepatitis C antibody result at screening.
- Administration of live vaccines starting from 6 weeks before first dose of study medication
- Subject has a history of malignancy (except lymphoma) within 3 years before the first dose of study medication or has evidence of residual disease from a previously diagnosed malignancy, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
- Subject has a previous diagnosis of lymphoma that has been treated with chemotherapy, radiotherapy, or transplant within 1 year of the first dose of study medication or is anticipated to require lymphoma treatment within 6 months of the first dose of study medication.
- Subject has uncontrolled post-transplant lymphoproliferative disease-like Epstein-Barr virus related lymphoproliferative disease.
- Donation or loss of 400mL or more of blood within 8 weeks before the first dose of study medication
- Subject has had major surgery requiring hospitalization or radiotherapy within 4 weeks prior to the first dose of study medication or has a planned or expected major surgical procedure during the study period.
- Pregnant or nursing (lactating) women.
- Individuals of child-bearing potential, unless they are using highly effective methods of contraception
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States5 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
National Institute of Health
Bethesda, Maryland, 20892
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Texas Children's Hospital
Houston, Texas, 77030
Mount Sinai Hospital
New York, New York, 10029
About this study
Official title: A Study to Assess Safety and Tolerability, and Explore Efficacy of Leniolisib for Immune Dysregulation in Common Variable Immunodeficiency (CVID)
In this study, common variable immunodeficiency (CVID) patients will all receive the study drug, leniolisib, for a treatment period of 6 months. Participants will start on a lower dose of leniolisib, followed by a mid and then a higher dose level. The primary goal is to assess the safety and tolerability of leniolisib, and secondary goal is to assess the potential for leniolisib to provide benefits for patients.
Read the detailed description
The study includes administration of increasing dose levels of leniolisib in approximately 20 CVID patients presenting with clinical manifestations of immune dysregulation at study entry. Enrollment will include both patients without and those with genetic drivers identified for their CVID.
All subjects participating will receive leniolisib film-coated tablets (FCTs) with a planned dose regimen consisting of a starting dose of 10 mg twice daily (BID) for 4 weeks, followed by a dose escalation to 30 mg BID for 4 weeks, and then 70 mg BID for an additional 16 weeks. Dose adjustments are allowed during treatment if deemed clinically necessary.
Subjects not continuing leniolisib treatment outside the current protocol will be followed up, with the EoS visit planned to occur approximately 28 days after last dose of leniolisib.
- Conditions
- Common Variable Immunodeficiency (CVID)
- Being tested
- Leniolisib
- Medical subject headings
- Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeniolisibDrug
Also called Joenja
Planned dose will range from 10 mg twice daily to 70 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Leniolisib | Experimental | All subjects participating will receive leniolisib film-coated tablets (FCTs) with a planned dose regimen consisting of a starting dose of 10 mg twice daily (BID) for 4 weeks, followed by a dose escalation to 30 mg BID for 4 weeks, and then 70 mg BID for an additional 16 weeks. Receives: Drug: Leniolisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Tolerability
To assess the number of AEs/SAEs and number of participants with AEs/SAEs
Measured: From baseline to the end of 24 weeks of treatment
Secondary outcomes (17)
Impact of leniolisib on lymphoproliferation measured as index lesions
Percent change from baseline in lymphadenopathy measured as the sum of product of diameters (SPD) in the index lesions selected per the Cheson methodology
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on lymphoproliferation measured as non-index lesions
Percent change from baseline in lymphadenopathy measured as SPD of measurable non-index lesions selected as per the Cheson methodology
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on spleen size
Percent change from baseline in splenomegaly measured by three-dimensional (3D) volume and bi-dimensional (2D) size of spleen
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on hemoglobin
Hemoglobin will be evaluated over time
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on platelets
Platelet count will be evaluated over time
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on neutrophils
Absolute neutrophil counts will be evaluated over time
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on GLILD or other PID-related ILD
The change in CT evidence of GLILD or other PID-related ILD over time will be compared using the Hartmann Scoring Methodology
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on pulmonary function in FEV1
Change in FEV1 will be evaluated
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on pulmonary function in FVC
Change in FVC will be evaluated
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on pulmonary function in TLC
Change in TLC will be evaluated
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on pulmonary function in DLCO
Change in DLCO will be evaluated
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on B and T cell subsets of interest
The percentages of naïve B cells, CD21low B cells, and T regulatory cells over time
Measured: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on CXCL13 and soluble IL-2Rα levels
The levels of CXCL13 and soluble IL-2Rα over time
Measured: From baseline to the end of 24 weeks of treatment
To assess the PK of leniolisib in CVID (Cmax)
PK parameters for leniolisib defined by Cmax
Measured: From baseline to the end of 24 weeks of treatment
To assess the PK of leniolisib in CVID (AUC0-t)
PK parameters for leniolisib defined by AUC0-t
Measured: From baseline to the end of 24 weeks of treatment
To assess the PK of leniolisib in CVID (Tmax)
PK parameters for leniolisib defined by Tmax
Measured: From baseline to the end of 24 weeks of treatment
To assess the PK of leniolisib in CVID (T½)
PK parameters for leniolisib defined by T½
Measured: From baseline to the end of 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start12 Feb 2025
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Variable Immunodeficiency (CVID)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharming Technologies B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lahey Hospital & Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897358
- Sponsor's protocol ID
- LE 8201
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Safety and Tolerability, and Explore Efficacy of Leniolisib for Immune Dysregulation in Common Variable Immunodeficiency (CVID)
- ClinicalTrials.gov ID
- NCT06897358
- Acronym / sponsor ID
- LE 8201
- Conditions
- Common Variable Immunodeficiency (CVID)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Pharming Technologies B.V.Industry (pharma, biotech, devices)
- Collaborators
- Lahey Hospital & Medical Center
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, common variable immunodeficiency (CVID) patients will all receive the study drug, leniolisib, for a treatment period of 6 months. Participants will start on a lower dose of leniolisib, followed by a mid and then a higher dose level. The primary goal is to assess the safety and tolerability of leniolisib, and secondary goal is to assess the potential for leniolisib to provide benefits for patients.
Detailed description
The study includes administration of increasing dose levels of leniolisib in approximately 20 CVID patients presenting with clinical manifestations of immune dysregulation at study entry. Enrollment will include both patients without and those with genetic drivers identified for their CVID.
All subjects participating will receive leniolisib film-coated tablets (FCTs) with a planned dose regimen consisting of a starting dose of 10 mg twice daily (BID) for 4 weeks, followed by a dose escalation to 30 mg BID for 4 weeks, and then 70 mg BID for an additional 16 weeks. Dose adjustments are allowed during treatment if deemed clinically necessary.
Subjects not continuing leniolisib treatment outside the current protocol will be followed up, with the EoS visit planned to occur approximately 28 days after last dose of leniolisib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leniolisib | Experimental | Drug: LeniolisibAll subjects participating will receive leniolisib film-coated tablets (FCTs) with a planned dose regimen consisting of a starting dose of 10 mg twice daily (BID) for 4 weeks, followed by a dose escalation to 30 mg BID for 4 weeks, and then 70 mg BID for an additional 16 weeks. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Subject is 12 to 75 years of age (inclusive).
- Subject must have a minimum body weight of 45 kg
- Subject has a clinical diagnosis of CVID supported by all of the following (a thru c):
- Inborn Errors of Immunity/ PID Panel testing:
- Subject has lymphoproliferation, as evidenced by CT imaging: splenomegaly with craniocaudal spleen measurement >10 cm and/or lymphadenopathy with at least 1 measurable index lymph node (long axis >1.5 cm) as per Cheson methodology.
Key exclusion criteria (35 listed)
- Laboratory evidence of significant T cell deficiency including CD4+ T cells <200/uL.
- Laboratory evidence of significant NK cell deficiency including NK cells <1% of peripheral blood lymphocytes or less than 50/mcL.
- Clinical history of infections suggestive of clinically significant T cell or NK cell deficiency such as Pneumocystis jirovecii, atypical mycobacteria, severe warts, or unusually severe (as determined by the PI) infections with herpesviruses.
- Presence of uncontrolled chronic/recurrent infectious disease (except those considered to be characteristic of antibody deficiency).
- Positive blood polymerase chain reaction (PCR) for cytomegalovirus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeniolisibAlso: JoenjaPlanned dose will range from 10 mg twice daily to 70 mg twice daily | Drug | Leniolisib |
Primary outcome
Safety & Tolerability
Time frame: From baseline to the end of 24 weeks of treatment
To assess the number of AEs/SAEs and number of participants with AEs/SAEs
17 secondary outcomes
Impact of leniolisib on lymphoproliferation measured as index lesions
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on lymphoproliferation measured as non-index lesions
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on spleen size
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on hemoglobin
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on platelets
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on neutrophils
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on GLILD or other PID-related ILD
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on pulmonary function in FEV1
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on pulmonary function in FVC
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on pulmonary function in TLC
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on pulmonary function in DLCO
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on B and T cell subsets of interest
Time frame: From baseline to the end of 24 weeks of treatment
Impact of leniolisib on CXCL13 and soluble IL-2Rα levels
Time frame: From baseline to the end of 24 weeks of treatment
To assess the PK of leniolisib in CVID (Cmax)
Time frame: From baseline to the end of 24 weeks of treatment
To assess the PK of leniolisib in CVID (AUC0-t)
Time frame: From baseline to the end of 24 weeks of treatment
To assess the PK of leniolisib in CVID (Tmax)
Time frame: From baseline to the end of 24 weeks of treatment
To assess the PK of leniolisib in CVID (T½)
Time frame: From baseline to the end of 24 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leniolisib in people with Common Variable Immunodeficiency (CVID), run by Pharming Technologies B.V. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety & Tolerability (time frame: From baseline to the end of 24 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.