Using camrelizumab to treat recurrent primary central nervous system lymphoma

An Exploratory Study on Camrelizumab（SHR-1210）for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

This study is testing if a new drug called camrelizumab can help people with recurrent primary central nervous system lymphoma feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Sanbo Brain Hospital (Academic / other)
• Drugs / interventions: methotrexate, camrelizumab
• Locations: 1 site (Beijing)
• Trial ID: NCT04070040 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of camrelizumab, a PD-1 inhibitor, in patients with recurrent primary central nervous system lymphoma (PCNSL). PCNSL is a rare type of non-Hodgkin lymphoma that affects the brain and surrounding areas, and treatment options for recurrent cases are limited. The trial aims to improve the objective response rate in these patients by administering camrelizumab and monitoring their response through imaging and clinical assessments. Participants will be closely monitored for safety and treatment outcomes throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of recurrent primary diffuse large B-cell lymphoma of the central nervous system.

Not a fit: Patients with serious organ dysfunction or those who have not had a confirmed recurrence of PCNSL may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent PCNSL, potentially improving their response rates and overall outcomes.

How similar studies have performed: While there have been studies on PD-1 inhibitors in other cancers, this specific application in recurrent PCNSL is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;
2. Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;
3. Measurable focus in MRI (\>10x10mm);
4. Aged \> 18 years;
5. Life expectancy of at least 12 weeks;
6. The patient has a Karnofsky performance status of at least 50%;
7. Main organs function normally, without serious blood, heart, lung, liver, kidney and immune deficiency diseases. Specific assay indicators requirements： White blood cells\>3.0×10\^9/L;platelet\>80×10\^9/L;hemoglobin\>10g/dL;serum bilirubin ≤ 1.5×ULN;ALT and AST ≤ 2×ULN;serum creatinine≤1.5mg/dL;
8. Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration;
9. The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form;

Exclusion Criteria:

1. Concurrent administration of any other antitumor therapy；
2. Allergic to the ingredients of research drugs；
3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent；
4. Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function；
5. Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for a maximum dose of 4 mg/day dexamethasone or equivalent doses of other corticosteroids or control of brain edema, which has been stable or decreased for at least 1 week prior to inclusion;
6. Active infection;
7. Risk of bleeding;
8. HIV positivity;
9. Pregnancy and lactation;

Where this trial is running

Beijing

• Sanbo Brain Hospital Capital Medical University — Beijing, China (Recruiting)

Conditions Primary Central Nervous System Lymphoma