Phase 2 Lymphoma Trial, Recruiting NCT04889716 Sponsor: Abramson Cancer Center at Penn Medicine Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT04889716
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:

  • People whose doctors estimate they have a life expectancy of at least 12 weeks.
  • People who have been diagnosed with large B-cell lymphoma (including certain related types called transformed follicular lymphoma and follicular lymphoma Grade 3B) that has come back or stopped responding to treatment, and who have already tried at least one treatment plan that included specific chemotherapy drugs (an anthracycline) and at least one treatment targeting a protein called CD20, and for whom no other treatment is expected to improve survival.
  • People who had a PET/CT scan, CT scan, or MRI taken within 56 days before receiving CAR-T cell therapy, showing at least one measurable area of disease of a certain minimum size.
  • People who had a follow-up PET/CT scan, CT scan, or MRI taken at least 28 days after their CAR-T cell treatment (and before starting this study's treatment), again showing at least one measurable area of disease.
  • People who are enrolling in the study at least 30 days after receiving their CAR-T cell infusion.
  • People whose recent blood and laboratory test results meet the required health thresholds (confirm with trial site).
  • People who are willing and able to use appropriate contraception as required by the study.

Who may not be able to join:

  • People who experienced a severe (Grade 3 or higher) immune reaction called cytokine release syndrome (CRS) after CAR-T therapy, or who still have ongoing CRS.
  • People who experienced moderate or severe nervous system side effects (Grade 2 or higher) after CAR-T therapy, or who currently have active neurological symptoms related to CAR-T treatment.
  • People who, in the investigator's judgment, would be unable to follow the study's requirements for hospital stays and activity restrictions.
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 3 months after the last dose of one of the study drugs, or within 18 months after the last dose of another study drug (whichever is later).
  • People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant).
  • People with an active autoimmune disease or any condition that currently requires long-term immune-suppressing medication.
  • People with a history of a serious brain infection called progressive multifocal leukoencephalopathy (PML).
  • People who have had a severe or life-threatening allergic reaction to a type of drug called a monoclonal antibody or a related antibody-based therapy.
  • People with a history of another cancer that could interfere with the study or make results harder to interpret.
  • People with serious heart conditions, such as severe heart failure, a heart attack within the past 6 months, unstable heart rhythm problems, or unstable chest pain.
  • People with serious active lung disease that currently requires oxygen or steroid treatment.
  • People with a known active infection (bacterial, viral, fungal, or other) at the time of enrolment, or who were hospitalised or treated with intravenous antibiotics for a significant infection within 2 weeks before starting the study treatment.
  • People who have had major surgery within 4 weeks before starting the study treatment.
  • People with ongoing or chronic infections that could increase the risk of serious side effects from the study drugs.
  • People who have received a live vaccine within 4 weeks before starting the study, or who are expected to need one during the study.
  • People who have taken certain immune-suppressing medications within 2 weeks before starting the study, except for low-dose steroid use below a specified threshold (confirm with trial site).
  • People with a history of drug or alcohol misuse within the 12 months before screening, in the investigator's judgment.
  • People with any other serious medical condition or abnormal test results that, in the investigator's judgment, would make participation unsafe or affect the reliability of study results.

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 21 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

Principal Investigator: Stephen J. Schuster, MD, University of Pennsylvania

Phone: 215-615-5858

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
Abramson Cancer Center at Penn Medicine
Registry
ClinicalTrials.gov
Start date
5 November 2021
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Assessment of the percentage of subjects who achieve a complete metabolic response at 24 weeks from date of first infusion as measured by Cheson 14 (ie Lugano) criteria; Assessment of the percentage of subjects who experience non-hematologic dose limiting toxicity associated with early administration of glofitimab following SOC CAR-T Cell 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: 21 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