Phase 2 Lymphoma Trial, Recruiting NCT06918912 Sponsor: Istituto Clinico Humanitas Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT06918912
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older, of any gender.
  • People who are able to give written consent to participate.
  • People whose general health and ability to carry out daily activities falls within an acceptable range, as rated by their doctor on a standard scale (ECOG score of 0 to 2).
  • People with a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL), non-Hodgkin lymphoma, or High-Grade B-Cell Lymphoma (HGBCL), including certain subtypes with specific genetic changes (MYC, BCL2, and/or BCL6 rearrangements).
  • People whose lymphoma has come back or stopped responding after a previous treatment called CAR-T cell therapy, meeting specific response criteria at defined timepoints after that treatment.
  • People whose disease can be measured on imaging scans (PET-CT, CT, or MRI), as defined by standard medical guidelines.
  • People who have previously been treated with a drug called Loncastuximab Tesirina, provided their disease was responding fully or partially when that treatment was stopped.
  • Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose.
  • Women who could become pregnant must agree to use highly effective contraception from the time of consent until at least 9 months after the last dose; men with partners who could become pregnant must agree to use highly effective contraception until at least 6 months after the last dose.
  • People whose kidneys, liver, lungs, and heart are functioning at an adequate level, as confirmed by specific blood and heart tests (confirm with trial site for exact values).
  • People whose blood cell counts — including white blood cells, red blood cells, and platelets — meet minimum required levels (confirm with trial site for exact values).

Who may not be able to join:

  • People with a known allergy or sensitivity to Loncastuximab Tesirina or any of its ingredients.
  • Women who are pregnant or breastfeeding.
  • People who have another active cancer, with some exceptions such as certain skin cancers, non-spreading prostate cancer, or early-stage cancers of the cervix or breast that the doctor considers unlikely to interfere with the study.
  • People whose lymphoma has spread to the brain or spinal cord, including the membranes surrounding them.
  • People with a tumour mass larger than 10 cm in diameter.
  • People who have HIV, hepatitis B, or hepatitis C that requires antiviral treatment.
  • People with a significant build-up of fluid in the body (such as in the abdomen or around the lungs) that needs to be drained or is causing breathing difficulties.
  • People with serious ongoing health conditions, including uncontrolled high blood pressure, unstable chest pain, severe heart failure, a heart attack or heart procedure within the past 6 months, uncontrolled irregular heartbeat, poorly controlled diabetes, or severe chronic lung disease.
  • People with an active autoimmune disease, particularly one affecting the nervous system.
  • People with a history of severe skin reactions known as Stevens-Johnson syndrome or toxic epidermal necrolysis.
  • People who have received chemotherapy, radiotherapy, or other cancer treatments within the 14 days before starting the study drug (unless approved by the study sponsor).
  • People who are planning to receive a live vaccine after the first dose of the study drug.
  • People who have taken another experimental drug or participated in another experimental therapy within 14 days before the first dose.
  • People who have not yet recovered from side effects of previous chemotherapy or radiation to an acceptable level before screening.
  • People with any other medical condition that the doctor running the trial considers would make participation unsafe or unsuitable.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +39 02 8224 4577

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Istituto Clinico Humanitas
Registry
ClinicalTrials.gov
Start date
16 June 2023
Est. completion
4 March 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Overall Response Rate (ORR) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) Following Failure of CAR-T Therapy After Treatment with Loncastuximab Tesirine

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov