Central Nervous System LymphomaPhase 1SOLARNCT06607549
Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR)
A Phase 1 study testing Loncastuximab tesirine and rituximab (Lonca-R) in people with Central Nervous System Lymphoma, run by University of Utah at 3 sites in United States.
Trial summary
The purpose of this clinical trial is to learn if drugs loncastuximab tesirine and rituximab (lonca-R) after stereotactic radiosurgery are safe and effective for treatment of central nervous system lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Lymphoma
- What is being tested?
- Loncastuximab tesirine and rituximab (Lonca-R)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Mar 2025to Nov 2030
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant aged ≥ 18 years
- ECOG Performance Status ≤ 3
- Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) with CNS involvement with either:
- Relapsed or refractory disease with at least 1 prior therapy OR
- Ineligible for high-dose methotrexate-based therapy as determined by the treating physician, including previously untreated patients. Examples of medical conditions for which a patient could be considered ineligible for high-dose methotrexate include but not limited to renal impairment, liver disease, heart failure.
- Note: For patients with a history of histologically documented systemic DLBCL with CNS relapse, a biopsy of the CNS lesion is recommended but not required.
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- Must be a candidate for SRS. Lesion size must be < 6 cm and the number of lesions must be < 10.
- Must have evaluable disease. This includes radiographic evidence of parenchymal disease or parenchymal disease and disease detected in the CSF.
- Patients with vitreous or retinal involvement alone are not eligible.
- Patients with leptomeningeal disease or spinal cord disease are not eligible.
- Adequate organ function as defined as:
- Hematologic:
- Absolute neutrophil count ≥ 1000 cells/mm3 (1.00 x 109/L) independent of G-CSF support (i.e. no G-CSF within the past 3 days) unless there is documented bone marrow involvement.
- Platelet count ≥ 75,000 cells/mm3 (75 x 109/L) independent of transfusion support (i.e. no transfusion within the past 3 days) unless there is documented bone marrow involvement.
- Hemoglobin ≥ 8 g/dL (≥ 80 g/L) independent of transfusion support (i.e. no transfusion within the past 3 days) unless there is documented bone marrow involvement.
- Hepatic:
- ---Total bilirubin ≤ 2.0 mg/dL (unless bilirubin rise is due to Gilbert's syndrome), if total bilirubin is > 2.0 mg/dL, the subject is eligible for the study if the direct bilirubin is normal; transaminases (AST/ALT) ≤2.5 x upper limit of normal (ULN)
- Renal:
- Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
- Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
- Females: (((140-age)×weight[kg])/(serum creatinine [mg/dL]×72))×0.85
- For subjects of childbearing potential: Negative pregnancy test or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
- < 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago
- Female participants of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1 until 10 months after last dose of loncastuximab tesirine and 12 months after the last dose of rituximab. Male participants with female partners of childbearing potential must agree to use a highly effective method of contraception when sexually active until 7 months after the last dose of loncastuximab tesirine.
- Provide written informed consent and comply with the study protocol as judged by the Investigator. Of note, if the subject has an impairment that prevents him/her from providing consent, the site may follow approved institutional procedures for obtaining consent. The investigator should document when a potential or current participant lacks decision-making capacity and thus requires an LAR to provide consent.
Who cannot join
- Concurrent use of other approved or investigational antineoplastic agents (with the exception of corticosteroids).
- History of intracranial hemorrhage or clinically significant stroke within 6 months prior to enrollment
- History of prior radiation to the CNS.
- Significant medical diseases or conditions, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction in the past 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, severely immunocompromised state, and congestive heart failure, New York Heart Association Class III-IV.
- Known bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.
- Known Human immunodeficiency virus (HIV) infection.
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- Prior allogeneic stem cell transplant for lymphoma (autologous stem cell transplant is NOT an exclusion).
- Prior exposure to loncastuximab tesirine
- Chemotherapy or targeted small molecule therapy (or other therapy for CNS lymphoma) within 3 weeks prior to the first day of Lonca-R (or 5 half-lives (whichever is shorter), or 2 weeks prior to the first day of Lonca-R for monoclonal antibodies.
- The patient must have recovered to baseline or ≤ grade 1 from prior toxicities of therapy with the exception of alopecia and myelosuppression provided lab criteria met. Recovery to ≤ grade 2 neuropathy is permitted.
- Cellular therapy (CAR-T or Bispecific antibodies) within 8 weeks.
- Presence of clinically significant pericardial or pleural effusions, or third space fluid accumulations (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
- Congenital long QT syndrome or a corrected QT measure (QTc) interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block).
- Known history of hypersensitivity to CD19 antibody and/or, components of study medication.
- All subjects must be screened for hepatitis B and C. Patients with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Patients who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing. Subjects with active Hep C patients may be enrolled if other parameters precluding hepatic impairment are met and they are not undergoing active therapy for hepatitis C.
- Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening.
- Subjects with chronic liver disease with hepatic impairment Child-Pugh class C
- Pregnant or lactating or intending to become pregnant during the study.
- Patients diagnosed with another malignancy within three years or with any evidence of residual prior malignant disease (except nonmelanoma skin cancer, non-metastatic prostate cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ). Patients meeting this exclusion criteria may be enrolled after approval from study PI.
- Unable to tolerate corticosteroids
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
Sidney Kimmel Comprehensive Cancer Center at Jefferson
Philadelphia, Pennsylvania, 19107
Alexandria Elkins, alexandria.elkins@jefferson.edu
Iyad Alnahhas, MD
- Recruiting
Brown University Health Rhode Island Hospital
Providence, Rhode Island, 02903
Andrew Schumacher, aschumacher@brownhealth.org
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, rachel.kingsford@hci.utah.edu
About this study
Official title: A Phase 1 Study of Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery (SRS) in Patients With Primary and Secondary Central Nervous System Lymphomas
The purpose of this clinical trial is to learn if drugs loncastuximab tesirine and rituximab (lonca-R) after stereotactic radiosurgery are safe and effective for treatment of central nervous system lymphomas.
- Conditions
- Central Nervous System Lymphoma
- Being tested
- Loncastuximab tesirine and rituximab (Lonca-R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loncastuximab tesirine and rituximab (Lonca-R)Drug
Patients will receive stereotactic radiosurgery (SRS) followed by a brain MRI approx. 3 weeks after SRS. This will be followed by loncastuximab tesirine and rituximab administered intravenously for a total of 6 cycles (every 21 days).
| Study group | Role | What they receive |
|---|---|---|
| Treatment: All Patients | Experimental | This study has two main goals:
Goal 1: The study will investigate the safety and tolerability of loncastuximab tesirine and rituximab (lonca-R).
Goal 2: The study will determine the maximum tolerated dose of lonca-R. Receives: Drug: Loncastuximab tesirine and rituximab (Lonca-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A safe and tolerable dose of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
Maximum Tolerated Dose (MTD): MTD is defined as the highest dose under consideration that has an estimated DLT probability below 25% based upon the Bayesian optimal interval design. The MTD will be decided based on the BOIN decision rules set for phase 1a portion of the study.
Measured: 5 years
Secondary outcomes (3)
To assess best overall response rate (ORR) following lonca-R
To evaluate the preliminary efficacy (ORR) of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
Measured: 6 months
To assess best complete response (CR) rate following lonca-R.
To evaluate the preliminary efficacy (complete response rate) of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
Measured: 6 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
To determine the safety and tolerability of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start18 Mar 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Responsible party
- Sponsor
- Investigators
- Narendranath Epperla, MD, MS, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607549
- Sponsor's protocol ID
- HCI181535
- Other IDs
- NCI-2024-09549
- Acronym
- SOLAR
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery (SRS) in Patients With Primary and Secondary Central Nervous System Lymphomas
- ClinicalTrials.gov ID
- NCT06607549
- Acronym / sponsor ID
- SOLAR / HCI181535
- Conditions
- Central Nervous System Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 23 Sep 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.
The purpose of this clinical trial is to learn if drugs loncastuximab tesirine and rituximab (lonca-R) after stereotactic radiosurgery are safe and effective for treatment of central nervous system lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: All Patients | Experimental | Drug: Loncastuximab tesirine and rituximab (Lonca-R)This study has two main goals: Goal 1: The study will investigate the safety and tolerability of loncastuximab tesirine and rituximab (lonca-R). Goal 2: The study will determine the maximum tolerated dose of lonca-R. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Participant aged ≥ 18 years
- ECOG Performance Status ≤ 3
- Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) with CNS involvement with either:
- Must be a candidate for SRS. Lesion size must be < 6 cm and the number of lesions must be < 10.
- Must have evaluable disease. This includes radiographic evidence of parenchymal disease or parenchymal disease and disease detected in the CSF.
Key exclusion criteria (20 listed)
- Concurrent use of other approved or investigational antineoplastic agents (with the exception of corticosteroids).
- History of intracranial hemorrhage or clinically significant stroke within 6 months prior to enrollment
- History of prior radiation to the CNS.
- Significant medical diseases or conditions, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction in the past 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, severely immunocompromised state, and congestive heart failure, New York Heart Association Class III-IV.
- Known bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.
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 |
|---|---|---|
| Loncastuximab tesirine and rituximab (Lonca-R)Patients will receive stereotactic radiosurgery (SRS) followed by a brain MRI approx. 3 weeks after SRS. This will be followed by loncastuximab tesirine and rituximab administered intravenously for a total of 6 cycles (every 21 days). | Drug | Treatment: All Patients |
Primary outcome
A safe and tolerable dose of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy.
Time frame: 5 years
Maximum Tolerated Dose (MTD): MTD is defined as the highest dose under consideration that has an estimated DLT probability below 25% based upon the Bayesian optimal interval design. The MTD will be decided based on the BOIN decision rules set for phase 1a portion of the study.
3 secondary outcomes
To assess best overall response rate (ORR) following lonca-R
Time frame: 6 months
To assess best complete response (CR) rate following lonca-R.
Time frame: 6 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
Time frame: 5 years
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Narendranath Epperla, MD, MS principal investigator
Huntsman Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Loncastuximab tesirine and rituximab (Lonca-R) in people with Central Nervous System Lymphoma, run by University of Utah 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 31 inclusion and 20 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 10 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Rachel Kingsford (801-585-0115, Rachel.Kingsford@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A safe and tolerable dose of lonca-R following SRS in patients with CNS lymphoma who have relapsed disease or are untreated and not candidates for HDMTX-based therapy. (time frame: 5 years). 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 10 Aug 2026.