Treatment with Brincidofovir for patients with relapsed lymphoma
Official title: A Multi-Center, Global, Open-Label, Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma As Well As to Evaluate the Safety and Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma Using The Recommended Phase 2 Dose
Run by SymBio Pharmaceuticals · NCT06761677 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a new drug called Brincidofovir can help people with relapsed lymphoma feel better and improve their treatment options.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 43 (estimated) |
| Sponsor | SymBio Pharmaceuticals Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Chuo-ku and 3 other locations) |
| Trial ID | NCT06761677 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histopathologically confirmed relapsed or refractory lymphoma who have previously undergone systemic chemotherapy.
✕Probably not a fit
Patients who have not been previously treated with systemic chemotherapy or those with other types of lymphoma not specified in the eligibility criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a multi-center, global, open-label study assessing the safety and efficacy of Brincidofovir in patients with relapsed or refractory lymphoma, including Extranodal Natural Killer/T-cell Lymphoma (ENKL). The study is divided into two parts, with a total enrollment of up to 43 participants, focusing on determining the maximum tolerated dose and preliminary efficacy of the treatment. Participants will be monitored for safety, tolerability, and pharmacokinetics of the drug across various cohorts. The trial is being conducted in multiple countries, including Japan, Korea, and Singapore.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat relapsed or refractory lymphomas.
How similar studies have gone: While this approach is novel for this specific patient population, similar studies have shown promise in treating other types of lymphoma with targeted therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are histopathologically diagnosed with ENKL based on the World Health Organization (WHO) Classification of Malignant Lymphoma 5th Edition (WHO-HAEM5) (can be enrolled in the Phase 1b part and the Phase 2 part) or patients diagnosed with EBV-positive nodal T- and NK-cell lymphoma (EBV + nTNKCL), nodal T-follicular helper cell lymphoma (nTFHcL) (including angioimmunoblastic T-cell lymphoma (AITL) as defined in the WHO Classification, 4th Edition), peripheral T-cell lymphoma not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), diffuse large B-cell lymphoma (DLBCL) (e.g., DLBCL, NOS), or adult T-Cell Leukemia Lymphoma (ATLL) (can only be enrolled in the Phase 1b part) * Patients with relapsed or refractory lymphoma and previously treated with systemic chemotherapy (history of multidrug chemotherapy including L-asparaginase such as SMILE therapy for ENKL is mandatory) who are ineligible for other systemic therapies * Patients with the following Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): * Phase 1b part: 0-1 * Phase 2 part: 0-2 Exclusion Criteria: * Patients with another active malignant tumor requiring treatment * Patients with NCI-CTCAE Grade 2 or higher diarrhea (increase of 4 or more bowel movements per day compared to usual number of bowel movements) within 7 days prior to starting the first dose of BCV * Graft-Versus-Host Disease (GVHD) patients requiring immunosuppressive agents * Patients with a history of Cidofovir intolerance * Patients with a history of being diagnosed with cirrhosis
Where it's running
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National Cancer Center Hospital
Chuo-ku, Japan Recruiting -
Cancer Institute Hospital Of JFCR
Koto-ku, Japan Recruiting -
Okayama University Hospital
Okayama, Japan Recruiting -
Mie University Hospital
Tsu, Japan Recruiting
Study contacts
- Study coordinator: Kohji Shimasaki
- Email: MedInfo@symbiopharma.com
- Phone: +81-3-5472-1127
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating a new treatment for relapsed or refractory NK/T-cell lymphoma
This study is testing a new combination treatment for people with relapsed or hard-to-treat NK/T-cell lymphoma to see if it can help them when other treatments haven't worked.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.