Blood tests could reveal who benefits from Next-Gen lymphoma antibodies
NCT ID NCT07767799
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This observational study is looking at whether biological markers in blood, tumor tissue, and imaging scans can predict how well patients with B-cell non-Hodgkin lymphoma respond to treatment with novel monoclonal antibodies. Researchers will collect samples from about 1,000 adults receiving these therapies as part of routine care, and analyze genetic, immune, and metabolic features. The goal is to find patterns that could help doctors personalize treatment and improve outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Novel monoclonal antibodies (including bispecific antibodies, immunoconjugates, and naked antibodies) used as standard-of-care treatment
- What this could lead to
- If successful, this could help doctors predict which lymphoma patients will respond best to antibody therapies, potentially guiding more personalized treatment decisions.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. The findings may not apply to all patients or treatments, and the biomarkers studied may not reliably predict outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2041
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Being an observational translational study primarily aimed at descriptive and exploratory analyses, no formal statistical hypothesis testing is planned for BIO-FIL\_MAB. The sample size is therefore determined based on feasibility and the expected availability of patients participating in the parent FIL-MAB clinical cohort. Overall, it is anticipated that at least 1000 patients will be enrolled and followed, providing a robust population for integrated biology, immunology, and imaging analyses alongside clinical outcomes.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults (≥18 years old) are diagnosed with B-cell Non-Hodgkin Lymphoma; * Patients enrolled in the FIL\_MAB trial (provided by Informed Consent Form (ICF) signature) who are scheduled to receive treatment with novel monoclonal antibodies (NMABs), either as monotherapy or in combination with other therapies; * Written informed consent to participate in this study. Exclusion Criteria: * Patients not enrolled in the FIL\_MAB study. * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARSCoV-2; * Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA; * HIV seropositivity; * Refusal or inability to provide informed consent. * Refusal or inability to provide biological specimens.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
20 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dipartimento di Medicina Traslazionale e di Precisione - Istituto Ematologia - Policlinico Umberto I - Università "La Sapienza" - Roma
Roma, 00161, Italy
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Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, 33081, Italy
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Ematologia - ASST Spedali Civili di Brescia
Brescia, 25123, Italy
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Ematologia - Arcispedale Santa Maria Nuova - IRCCS -Azienda Unità Sanitaria Locale
Reggio Emilia, 42123, Italy
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Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, 20133, Italy
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Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Torino, 10060, Italy
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Ematologia - Ospedale S. Bortolo - ULSS 8 Berica
Vicenza, 36100, Italy
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Ematologia Universitaria - A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126, Italy
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Istituto di Ematologia "Seragnoli" - Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
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Oncoematologia IOV - Ospedale di Castelfranco Veneto
Castelfranco Veneto, Treviso, 31033, Italy
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S.C. Ematologia - A.O. S. Croce e Carle
Cuneo, 12100, Italy
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S.C. Ematologia - A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126, Italy
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SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
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SC Ematologia - Azienda Ospedaliera Papa Giovanni XXIII - Bergamo
Bergamo, 24127, Italy
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SCDU Ematologia - AOU Maggiore della Carità di Novara
Novara, 28100, Italy
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SCDU Ematologia -AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, 15121, Italy
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U.O. Ematologia - AOU Integrata di Verona
Verona, 37134, Italy
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U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II - Bari
Bari, 70124, Italy
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UOC Ematologia Dipartimento Oncologico Ematologico - P.O. Spirito Santo di Pescara - ASL Pescara
Pescara, 65124, Italy
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Unità funzionale di Ematologia -Azienda Ospedaliera Universitaria Careggi
Florence, 50141, Italy
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