Phase 2 Lymphoma Trial, Recruiting NCT05464719 Sponsor: M.D. Anderson Cancer Center Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05464719
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 diagnosed with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphoma, or high-grade B-cell lymphoma
  • People who received a standard-of-care, FDA-approved CAR T-cell therapy (targeting CD19) outside of a clinical trial
  • People aged 18 or older
  • People with a general health/activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities — confirm with trial site)
  • People whose cancer showed a partial response (meaning it reduced but did not fully disappear) about 30 days after CAR T-cell therapy, based on standard response criteria
  • People for whom at least 30 days have passed since their CAR T-cell therapy infusion
  • People whose cancer cells show no detectable CD19 protein after CAR T-cell therapy
  • People who have not received any additional cancer treatment after CAR T-cell therapy, except for palliative radiation therapy
  • People whose blood cell counts (white cells and platelets) are at acceptable levels without needing growth factor support or blood transfusions for at least 3 days before the screening assessment
  • People whose kidneys are functioning at an acceptable level (confirm with trial site)
  • People whose liver function tests are within acceptable ranges (confirm with trial site)
  • People whose heart is pumping adequately (at least 45% efficiency) with no significant fluid around the heart
  • People whose blood oxygen level is above 92% while breathing normal room air
  • People with no evidence or suspicion of lymphoma affecting the brain or spinal cord
  • Women who could potentially become pregnant must have a negative pregnancy test before joining
  • People who have fully recovered from any serious side effects (specifically CRS or ICANS) related to their CAR T-cell therapy

Who may not be able to join:

  • People with significant fluid build-up in the abdomen requiring drainage, or fluid around the lungs causing breathing difficulty
  • People with a history of another cancer (other than certain non-invasive or easily treated skin or localised cancers) unless they have been cancer-free for at least 12 months
  • People with a history of a specific transformation of chronic lymphocytic leukaemia (CLL) called Richter's transformation
  • People whose most recent treatment before this trial was CAR T-cell therapy received as part of another clinical trial
  • People who have previously been treated with loncastuximab tesirine (lonca)
  • People with an active infection that is not under control or that requires intravenous antibiotics (minor infections that are responding to treatment may be considered — confirm with trial site)
  • People with a known history of HIV, hepatitis B, or hepatitis C where the virus is still detectable in the blood
  • People with lymphoma actively involving the heart chambers
  • People who have had a heart attack, heart procedure, unstable chest pain, or other significant heart condition within the past 12 months
  • People with a primary immune system deficiency condition
  • People with a history of an autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has caused organ damage or required ongoing immune-suppressing treatment within the last 2 years
  • People with a history of a serious blood clot in the veins or lungs within 1 month of joining (at the investigator's discretion)
  • People with any medical condition that could interfere with safely assessing the treatment's effects
  • People with a history of a severe allergic reaction to any medication used in this trial
  • Women who are pregnant or breastfeeding, due to potential risks to the baby
  • People who are not willing to use effective contraception during and after the trial — women of childbearing potential must use highly effective contraception for 9 months after the last dose of lonca, and men with female partners who could become pregnant must use a condom for 6 months after the last dose
  • People who, in the investigator's judgement, are unlikely to complete all required trial visits and procedures

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 19 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: Paolo Strati, MD, M.D. Anderson Cancer Center

Phone: (713) 745-1776

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
Registry
ClinicalTrials.gov
Start date
23 September 2022
Est. completion
30 January 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of conversion to complete response

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: 19 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