Phase 1 Lymphoma Trial, Recruiting NCT06607549 Sponsor: University of Utah Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT06607549
Recruiting Phase 1

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:

  • People aged 18 or older
  • People whose overall health and ability to carry out daily activities meets a certain minimum level (measured on a standard scale used by doctors, called ECOG Performance Status of 3 or below)
  • People who have been diagnosed through a tissue biopsy with either primary CNS lymphoma (lymphoma that started in the brain or spinal cord) or a type of aggressive lymphoma called diffuse large B-cell lymphoma (DLBCL) that has spread to the brain or spinal cord, AND who either: have had the disease come back or stop responding to at least one previous treatment, OR have been assessed by their treating doctor as not suitable for a standard chemotherapy treatment called high-dose methotrexate (for example, due to kidney problems, liver disease, or heart failure)
  • People whose tumours are suitable for a focused radiation treatment called stereotactic radiosurgery (SRS) — meaning each tumour is smaller than 6 cm and there are fewer than 10 tumours in total
  • People who have measurable disease visible on brain scans or detectable in the fluid around the brain and spinal cord
  • People whose blood counts, liver function, and kidney function meet minimum levels set by the trial (a trial doctor will assess this through blood tests)
  • People who are not able to become pregnant, or people who are able to become pregnant but have a negative pregnancy test and agree to use highly effective contraception for a specified period after the last dose of study treatments; male participants with female partners who could become pregnant must also agree to use highly effective contraception for a set period after their last dose
  • People who are able to give written consent to participate, or who have a legally authorised representative who can do so on their behalf if they are unable to

Who may not be able to join:

  • People currently receiving other cancer treatments (other than corticosteroids/steroids)
  • People who have had bleeding in the brain or a significant stroke within the past 6 months
  • People who have previously had radiation treatment to the brain or spinal cord
  • People with serious medical conditions that a doctor determines would make the risks of the trial too high — including a heart attack in the past 6 months, unstable chest pain, uncontrolled diabetes, serious active infections, severely weakened immune system, or significant heart failure
  • People with known bleeding disorders (such as von Willebrand's disease or haemophilia) or who are actively bleeding
  • People with a known HIV infection
  • People who have previously had a donor (allogeneic) stem cell transplant — note that a transplant using the person's own cells (autologous) does not exclude participation
  • People who have previously received the study drug loncastuximab tesirine
  • People who have received chemotherapy, targeted cancer medicines, or other CNS lymphoma treatments too recently before the start of the trial (specific timeframes apply depending on the type of treatment — confirm with trial site)
  • People who have not yet recovered sufficiently from side effects of previous cancer treatments (with some exceptions — confirm with trial site)
  • People who received cellular therapy (such as CAR-T cell therapy) within the past 8 weeks
  • People with significant fluid build-up around the heart or lungs, or fluid accumulation in the abdomen requiring drainage
  • People with a heart condition called long QT syndrome, or whose heart electrical activity measurement (QTc interval) is above a certain level on a heart tracing (ECG) at the time of screening
  • People with a known allergy or sensitivity to CD19-targeting antibodies or to any ingredient in the study medications
  • People with active hepatitis B infection based on blood test results; people with certain hepatitis B markers may still be considered but would need to take preventive medication and have regular blood tests (confirm with trial site); people with hepatitis C may be considered in some circumstances if they are not currently being treated for it and liver function is otherwise acceptable (confirm with trial site)
  • People with an active infection (bacterial, viral, fungal, or other) that requires treatment at the time of screening
  • People with advanced chronic liver disease classified as Child-Pugh class C
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study
  • People who have been diagnosed with another cancer within the past three years, or who have any remaining signs of a previous cancer — though some exceptions apply (such as certain skin cancers, early-stage prostate cancer, or certain in situ cancers), and the lead researcher may grant approval in some cases (confirm with trial site)
  • People who are unable to tolerate steroid medications (corticosteroids)

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 16 July 2026
Phase 1: approximately ~10% 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

Principal Investigator: Narendranath Epperla, MD, MS, Huntsman Cancer Institute/ University of Utah

Phone: 801-585-0115

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 1
Registry
ClinicalTrials.gov
Start date
18 March 2025
Est. completion
1 November 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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.

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: 16 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