Autoimmune Lymphoproliferative SyndromePhase 2NCT06730126
Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
A Phase 2 study testing Soquelitinib in people with Autoimmune Lymphoproliferative Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
Background: Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes. This can lead to an enlarged spleen and lymph nodes. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Autoimmune Lymphoproliferative Syndrome
- What is being tested?
- Soquelitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Mar 2025to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be eligible to participate in this study and to re-enroll, an individual must meet all the following criteria:
- Aged >= 16 years.
- Able to provide informed consent (for ages >= 18 years) or has a parent(s) or guardian(s) who can provide permission to participate on their behalf (for ages <18 years).
- Has a documented diagnosis of ALPS-FAS.
- Has clinical evidence of active disease, defined as at least one enlarged lymph node and/or enlarged spleen.
- If currently on corticosteroid therapy, then dose is less than 20 mg/day (prednisone equivalent) and has been stable for at least 4 weeks.
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- For participants to be seen at the NIH CC, co-enrolled on NIH protocol 93-I-0063.
- Participants who can become pregnant or who can impregnate their partner must agree to either remain sexually abstinent or use two highly effective methods of contraception when engaging in sexual activities that can result in pregnancy, beginning 28 days before baseline until 3 months after the last dose. One method must be a barrier (eg, internal or external condom, cervical cap, or diaphragm). The second method may be any of the following:
- 7a. Oral contraceptive pill or hormonal patch or ring.
- 7b. Parenteral hormonal contraceptive implant.
- 7c. Intrauterine device.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation or re-enrollment in this study:
- Profound grade 3 or 4 cytopenias that cannot be improved with immunomodulatory treatments prior to enrolling in the clinical trial and starting the study drug. Per investigator discretion, individuals on a single agent may be included if the dose is stable for 12 weeks at screening and is not expected to confer additive toxicity.
- Renal impairment, defined as serum creatinine >1.5 mg/dL (or 133 micromol/L) or estimated glomerular filtration rate <60 mL/min/1.73 m^2.
- Liver impairment, defined as bilirubin, alanine aminotransferase, or aspartate aminotransferase greater than 2.5 times the upper limit of normal.
- History of EBV-associated lymphoma.
- Active EBV infection with EBV load >300 copies/mL.
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- Tuberculosis infection (active or latent) or undergoing tuberculosis treatment.
- Infection with HIV or hepatitis B or C.
- Current other invasive or systemic fungal, bacterial, or viral infection requiring therapy.
- History of opportunistic infection within the previous 180 days.
- History of invasive malignancy that required systemic therapy within the last 3 years.
- Current use of moderate or strong cytochrome P450 isozyme (CYP)3A inhibitors or inducers that cannot be stopped before day 0.
- Current use of P-glycoprotein (P-gp) inhibitors that cannot be stopped before day 0.
- Known hypersensitivity or contraindication to CT contrast agent.
- Pregnant or breastfeeding.
- Any condition that, in the opinion of the study team contraindicates participation in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Alanvin Orpia, B.S.N., 240-669-2935, alanvin.orpia@nih.gov
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Carl Allen, 832-824-4312, ceallen@txch.org
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
David Teachey, 267-426-5802, teacheyd@chop.edu
About this study
Official title: A Phase 2a Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
Background:
Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes. This can lead to an enlarged spleen and lymph nodes. Current treatments for ALPS can have many adverse effects. Better treatments for ALPS are needed.
Read more
Objective:
To test a study drug (soquelitinib) in people with ALPS.
Eligibility:
People aged 16 years and older with ALPS.
Design:
Participants will have 8 clinic visits and 6 remote visits within 1 year.
Participants will be screened. They will have a physical exam with blood and urine tests. Some may have tests of their lung function.
Soquelitinib is a tablet taken by mouth twice a day. Participants will record their doses and any symptoms on a paper or online form.
Blood tests and other procedures will be repeated during study visits. Three visits will include imaging scans. Participants will lie on a table that slides through a doughnut-shaped machine while X-rays capture pictures of the inside of their body.
Some participants may be able to remain in the study for a second year....
Read the detailed description
Study Description:
This is a multisite open-label phase 2a study to evaluate the safety, tolerability, and preliminary efficacy of the interleukin (IL)-2 inducible T-cell kinase (ITK) inhibitor soquelitinib for treating ALPS-FAS. This study will be conducted in two stages. In the first stage, following a background drug washout of up to 90 days, 8 participants will receive 200 mg of soquelitinib twice daily for up to 360 days, with approximately monthly study visits (in person or remote). A safety and futility interim analysis will be conducted after all 8 participants have had a computed tomography (CT) or positron emission tomography (PET)/CT scan at day 90 and have completed at least 80% of their study drug regimen. If at least one participant has a positive response to the study drug and there are no safety concerns among the 8 participants, then the study will proceed to stage 2, in which 6 new participants will be enrolled and, following a background drug washout of up to 90 days, receive the same dosage as stage 1 (200 mg twice daily for 360 days). Individual participation concludes at the end of the 360-day regimen.
Participants may re-enroll once in the study. They will repeat the whole study schedule except for the screening visit, but they will have a study drug washout period of up to 90 days with monthly visits during that time. Upon reaching pre-specified criteria, they will begin a second 360-day regimen of soquelitinib at 200 mg twice daily.
The primary endpoints will be assessed after all 6 participants of stage 2 have had a CT or PET/CT scan at day 90 and have completed at least 80% of their study drug regimen. The trial will automatically be determined a failure if safety concerns or lack of positive response prevent progression to stage 2.
Primary Objectives:
To determine the efficacy of soquelitinib in reducing spleen volume or target lymph node volume in people with ALPS-FAS.
Secondary Objective:
- To determine the efficacy of soquelitinib in improvement of lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS.
- To determine the safety and tolerability of soquelitinib in people with ALPS-FAS.
Primary Endpoints:
Reduction of spleen volume or target lymph node volume by 25% from baseline to day 90, assessed by CT or PET/CT scan.
Secondary Endpoints:
- Shrinkage in spleen volume from baseline to day 90.
- Shrinkage in target lymph node volume from baseline to day 90.
- Reduction of cytopenias by one severity level from baseline to day 90.
- Reduction in prednisone dosage.
- Grade 3 or 4 systemic infections within 360 days (first or second regimen).
- Clinically significant worsening of viral, mycobacterial, or fungal infection requiring new treatment or change of treatment by day 360 (first or second regimen).
- Any drug-related grade 3 or 4 adverse event (AE) that triggers a pause.
- Conditions
- Autoimmune Lymphoproliferative Syndrome
- Being tested
- Soquelitinib
- Keywords
- Autoimmune Lymphoproliferative Syndrome, Fas, Hypersplenism, Lymphoproliferation, Interleukin-2 Inducible T-cell Kinase, Soquelitinib, Targeted Treatment
- Medical subject headings
- Autoimmune Lymphoproliferative Syndrome, Autoimmune Lymphoproliferative Syndrome, Type IA, Hypersplenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoquelitinibDrug
Soquelitinib is an ITK inhibitor in clinical development for treating relapsed/refractory T-cell lymphoma.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | The dosage for this study is 200 mg twice daily for up to 360 days. If the participant repeats they study they will receive the same dosage for up to an additional 360 days. Receives: Drug: Soquelitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of spleen volume or target lymph node volume by 25% from baseline to day 90, assessed by CT or PET/CT scan.
To determine the efficacy of soquelitinib in reducing spleen volume or target lymph node volume in people with ALPS-FAS.
Measured: Day 90
Secondary outcomes (7)
Shrinkage in spleen volume from baseline to day 90.
To determine the efficacy of soquelitinib in improvement in lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS.
Measured: Day 90
Shrinkage in target lymph node volume from baseline to day 90.
To determine the efficacy of soquelitinib in improvement in lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS.
Measured: Day 90
Reduction of cytopenias by one severity level from baseline to day 90
To determine the efficacy of soquelitinib in improvement in lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS and to determine the safety and tolerability of soquelitinib in people with ALPS-FAS.
Measured: Day 90
Reduction in prednisone dosage.
To determine the efficacy of soquelitinib in improvement in lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS
Measured: End of Study
Grade 3 or 4 systemic infections within 360 days.
To determine the safety and tolerability of soquelitinib in people with ALPS-FAS.
Measured: Day 360
Clinically significant worsening of viral, mycobacterial, or fungal infection requiring new treatment or change of treatment by day 360.
To determine the safety and tolerability of soquelitinib in people with ALPS-FAS.
Measured: End of Study
Any drug-related grade 3 or 4 AE AE that triggers a pause.
To determine the safety and tolerability of soquelitinib in people with ALPS-FAS.
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start10 Mar 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Lymphoproliferative SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- V. Koneti Rao, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730126
- Sponsor's protocol ID
- 10001824
- Other IDs
- 001824-I
- Status last verified
- 9 Jun 2026
- First submitted
- 11 Dec 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical, laboratory, imaging and demographic data.
Publications
Price S, Shaw PA, Seitz A, Joshi G, Davis J, Niemela JE, Perkins K, Hornung RL, Folio L, Rosenberg PS, Puck JM, Hsu AP, Lo B, Pittaluga S, Jaffe ES, Fleisher TA, Rao VK, Lenardo MJ. Natural history of autoimmune lymphoproliferative syndrome associated with FAS gene mutations. Blood. 2014 Mar 27;123(13):1989-99. doi: 10.1182/blood-2013-10-535393. Epub 2014 Jan 7.
PubMed 24398331
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
- ClinicalTrials.gov ID
- NCT06730126
- Acronym / sponsor ID
- 10001824
- Conditions
- Autoimmune Lymphoproliferative Syndrome
- Keywords
- Autoimmune Lymphoproliferative Syndrome, Fas, Hypersplenism, Lymphoproliferation, Interleukin-2 Inducible T-cell Kinase, Soquelitinib, Targeted Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Dec 2024 (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.
Background:
Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes. This can lead to an enlarged spleen and lymph nodes. Current treatments for ALPS can have many adverse effects. Better treatments for ALPS are needed.
Objective:
To test a study drug (soquelitinib) in people with ALPS.
Eligibility:
People aged 16 years and older with ALPS.
Design:
Participants will have 8 clinic visits and 6 remote visits within 1 year.
Participants will be screened. They will have a physical exam with blood and urine tests. Some may have tests of their lung function.
Soquelitinib is a tablet taken by mouth twice a day. Participants will record their doses and any symptoms on a paper or online form.
Blood tests and other procedures will be repeated during study visits. Three visits will include imaging scans. Participants will lie on a table that slides through a doughnut-shaped machine while X-rays capture pictures of the inside of their body.
Some participants may be able to remain in the study for a second year....
Detailed description
Study Description:
This is a multisite open-label phase 2a study to evaluate the safety, tolerability, and preliminary efficacy of the interleukin (IL)-2 inducible T-cell kinase (ITK) inhibitor soquelitinib for treating ALPS-FAS. This study will be conducted in two stages. In the first stage, following a background drug washout of up to 90 days, 8 participants will receive 200 mg of soquelitinib twice daily for up to 360 days, with approximately monthly study visits (in person or remote). A safety and futility interim analysis will be conducted after all 8 participants have had a computed tomography (CT) or positron emission tomography (PET)/CT scan at day 90 and have completed at least 80% of their study drug regimen. If at least one participant has a positive response to the study drug and there are no safety concerns among the 8 participants, then the study will proceed to stage 2, in which 6 new participants will be enrolled and, following a background drug washout of up to 90 days, receive the same dosage as stage 1 (200 mg twice daily for 360 days). Individual participation concludes at the end of the 360-day regimen.
Participants may re-enroll once in the study. They will repeat the whole study schedule except for the screening visit, but they will have a study drug washout period of up to 90 days with monthly visits during that time. Upon reaching pre-specified criteria, they will begin a second 360-day regimen of soquelitinib at 200 mg twice daily.
The primary endpoints will be assessed after all 6 participants of stage 2 have had a CT or PET/CT scan at day 90 and have completed at least 80% of their study drug regimen. The trial will automatically be determined a failure if safety concerns or lack of positive response prevent progression to stage 2.
Primary Objectives:
To determine the efficacy of soquelitinib in reducing spleen volume or target lymph node volume in people with ALPS-FAS.
Secondary Objective:
- To determine the efficacy of soquelitinib in improvement of lymphoproliferation and autoimmune disease, including cytopenias, in people with ALPS-FAS.
- To determine the safety and tolerability of soquelitinib in people with ALPS-FAS.
Primary Endpoints:
Reduction of spleen volume or target lymph node volume by 25% from baseline to day 90, assessed by CT or PET/CT scan.
Secondary Endpoints:
- Shrinkage in spleen volume from baseline to day 90.
- Shrinkage in target lymph node volume from baseline to day 90.
- Reduction of cytopenias by one severity level from baseline to day 90.
- Reduction in prednisone dosage.
- Grade 3 or 4 systemic infections within 360 days (first or second regimen).
- Clinically significant worsening of viral, mycobacterial, or fungal infection requiring new treatment or change of treatment by day 360 (first or second regimen).
- Any drug-related grade 3 or 4 adverse event (AE) that triggers a pause.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: SoquelitinibThe dosage for this study is 200 mg twice daily for up to 360 days. If the participant repeats they study they will receive the same dosage for up to an additional 360 days. |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- To be eligible to participate in this study and to re-enroll, an individual must meet all the following criteria:
- Aged >= 16 years.
- Able to provide informed consent (for ages >= 18 years) or has a parent(s) or guardian(s) who can provide permission to participate on their behalf (for ages <18 years).
- Has a documented diagnosis of ALPS-FAS.
- Has clinical evidence of active disease, defined as at least one enlarged lymph node and/or enlarged spleen.
Key exclusion criteria (16 listed)
- An individual who meets any of the following criteria will be excluded from participation or re-enrollment in this study:
- Profound grade 3 or 4 cytopenias that cannot be improved with immunomodulatory treatments prior to enrolling in the clinical trial and starting the study drug. Per investigator discretion, individuals on a single agent may be included if the dose is stable for 12 weeks at screening and is not expected to confer additive toxicity.
- Renal impairment, defined as serum creatinine >1.5 mg/dL (or 133 micromol/L) or estimated glomerular filtration rate <60 mL/min/1.73 m^2.
- Liver impairment, defined as bilirubin, alanine aminotransferase, or aspartate aminotransferase greater than 2.5 times the upper limit of normal.
- History of EBV-associated lymphoma.
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 |
|---|---|---|
| SoquelitinibSoquelitinib is an ITK inhibitor in clinical development for treating relapsed/refractory T-cell lymphoma. | Drug | Interventional |
Primary outcome
Reduction of spleen volume or target lymph node volume by 25% from baseline to day 90, assessed by CT or PET/CT scan.
Time frame: Day 90
To determine the efficacy of soquelitinib in reducing spleen volume or target lymph node volume in people with ALPS-FAS.
7 secondary outcomes
Shrinkage in spleen volume from baseline to day 90.
Time frame: Day 90
Shrinkage in target lymph node volume from baseline to day 90.
Time frame: Day 90
Reduction of cytopenias by one severity level from baseline to day 90
Time frame: Day 90
Reduction in prednisone dosage.
Time frame: End of Study
Grade 3 or 4 systemic infections within 360 days.
Time frame: Day 360
Clinically significant worsening of viral, mycobacterial, or fungal infection requiring new treatment or change of treatment by day 360.
Time frame: End of Study
Any drug-related grade 3 or 4 AE AE that triggers a pause.
Time frame: End of Study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 24398331Price S, Shaw PA, Seitz A, Joshi G, Davis J, Niemela JE, Perkins K, Hornung RL, Folio L, Rosenberg PS, Puck JM, Hsu AP, Lo B, Pittaluga S, Jaffe ES, Fleisher TA, Rao VK, Lenardo MJ. Natural history of autoimmune lymphoproliferative syndrome associated with FAS gene mutations. Blood. 2014 Mar 27;123(13):1989-99. doi: 10.1182/blood-2013-10-535393. Epub 2014 Jan 7.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Clinical, laboratory, imaging and demographic data.
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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.
V. Koneti Rao, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Soquelitinib in people with Autoimmune Lymphoproliferative Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alanvin D Orpia, R.N. ((240) 550-3663, alanvin.orpia@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of spleen volume or target lymph node volume by 25% from baseline to day 90, assessed by CT or PET/CT scan. (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06730126, which also lists 1 linked publication.
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 3 Nov 2026.