Phase 2 Lymphoma Trial, Recruiting NCT06788964 Sponsor: University of Utah Condition: Lymphoma
Back to Lymphoma

Phase 2 Lymphoma Trial, Recruiting

NCT06788964
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:

  • You are 18 years of age or older.
  • You are planned to receive an approved CAR-T cell therapy targeting CD19 (specifically axi-cel or liso-cel).
  • Your doctor has decided you need "bridging therapy" — treatment given while you wait for your CAR-T cell therapy.
  • You have been diagnosed with a specific type of aggressive B-cell lymphoma (including DLBCL, transformed follicular lymphoma, PMBCL, or certain high-grade B-cell lymphomas) that has come back or stopped responding to treatment after at least one previous combination treatment.
  • Your cancer can be detected and measured on scans (PET-CT, CT, or MRI).
  • You are reasonably active and able to care for yourself, with only limited restrictions on daily activities (confirm with trial site).
  • Enough time has passed since your last cancer treatment — the exact amount of time depends on what type of treatment you received (ranging from 14 days to 60 days).
  • Your blood counts, liver, and kidney functions are at acceptable levels as measured by blood tests.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test, or be confirmed post-menopausal or surgically sterile.
  • If you or your partner could become pregnant, you must agree to use highly effective contraception during the study.
  • You are able to understand and sign an informed consent form agreeing to take part.

Who may not be able to join:

  • You have previously received any treatment that targets CD19, including the study drug (lonca) or a CD19 CAR-T therapy before.
  • You are enrolled in another trial using an experimental CAR-T product.
  • You had major surgery within the 4 weeks before starting the study treatment.
  • You have a history of a bleeding disorder (such as von Willebrand's disease or haemophilia) or are currently experiencing active bleeding.
  • You have severe chronic liver disease (classified as Child-Pugh class C).
  • You are pregnant, breastfeeding, or planning to become pregnant during the study.
  • You have active graft-versus-host disease (a complication that can occur after a transplant).
  • You have a condition called post-transplantation lymphoproliferative disorder.
  • You have an active autoimmune disease that, in your doctor's opinion, could affect your safety or ability to participate.
  • You have another cancer diagnosis that your doctor believes could affect your safety or participation in the trial.
  • Your lymphoma has spread to your brain or central nervous system.
  • You have serious heart problems, including severe heart failure, recent heart attack (within 6 months), dangerous irregular heartbeats, or certain abnormalities on a heart tracing (ECG) (confirm with trial site).
  • You have severe lung disease, uncontrolled diabetes, or a severely weakened immune system.
  • You have an active infection (bacterial, viral, fungal, or other) that requires treatment at the time of screening.
  • You are living with HIV.
  • You have an active hepatitis B infection (certain hepatitis B cases may still be considered — confirm with trial site); active hepatitis C may be considered if you are not currently being treated for it and your liver function meets the required levels.
  • You have had a severe allergic reaction to a CD19-targeted antibody or to the study drug or any of its ingredients.
  • You are currently taking certain medications that are not allowed in this study and are unable to stop them for the required period beforehand (confirm with trial site).

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 2 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.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
25 August 2025
Est. completion
1 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The complete response (CR) rate at D30 post CAR-T(+/- 7 days) post CAR-T administration per Lugano 2014 criteria.; Duration of cytopenias post CAR-T (as defined by the NIH CTCAE, version 5.0) D30 post CAR-T (+/- 7 days).; Severity of cytopenias post CAR-T (as defined by the NIH CTCAE, version 5.0) D30 (+/- 7 days).; Rate of infections D30 (+/- 7 days).

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: 2 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