Phase 2 Lymphoma Trial, Recruiting NCT05554939 Sponsor: Chinese PLA General Hospital Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05554939
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 aged 18 to 75 years old (inclusive).
  • People who have been diagnosed through a biopsy with a type of B-cell non-Hodgkin lymphoma (a blood cancer) that tests positive for a protein called CD19, including specific subtypes such as diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, high-grade B-cell lymphoma with certain genetic changes, follicular lymphoma, mantle cell lymphoma, or marginal zone lymphoma.
  • People whose lymphoma has come back or stopped responding to at least 2 previous treatment courses (or, for more aggressive types, stopped responding to the first treatment course under specific conditions described by the trial).
  • People who have previously received certain specific treatments appropriate for their lymphoma type, such as chemotherapy containing particular drug types and targeted antibody therapies (confirm exact prior treatment requirements with the trial site).
  • People whose doctors estimate they have a life expectancy of more than 3 months.
  • People who are considered reasonably well and able to carry out basic daily activities, based on a standard medical assessment scale (ECOG score of 0–2).
  • People who have at least one measurable area of lymphoma visible on a CT or MRI scan, meeting specific size requirements.
  • People who are willing to provide a tissue sample, either through a new biopsy or by supplying preserved tissue from a previous biopsy.
  • People whose heart, kidney, liver, and lung function meet minimum levels set by the trial (confirm specific values with the trial site).
  • People whose blood cell counts (red cells, white cells, and platelets) are at or above minimum levels set by the trial, without the need for growth factor support.
  • Women of childbearing age whose pregnancy test result is negative, and all participants who agree to use effective contraception throughout treatment and for one year afterwards.
  • People whose side effects from previous cancer treatments have mostly resolved to a mild level or better.
  • People who do not have obvious hereditary diseases.
  • People who are able to understand what the trial involves and are willing to follow its requirements, and who are willing to sign an informed consent form.

Who may not be able to join:

  • People who have lymphoma that has spread to the brain or spinal cord, or who have a history of significant brain or nervous system conditions such as epilepsy or stroke-related disease.
  • Women who are pregnant or breastfeeding, or anyone who does not agree to use effective contraception during treatment and for one year afterwards.
  • People who have previously had a bone marrow or stem cell transplant using donor cells (allogeneic transplant), or an organ transplant.
  • People who have had another type of cancer that is not currently in remission.
  • People with conditions where the immune system does not work properly from birth, or autoimmune diseases that require ongoing immune-suppressing medication.
  • People who received radiotherapy within 3 months before joining the trial.
  • People who received certain immune-based drug therapies (such as PD-1, PD-L1, or CD19/CD3 antibody treatments) within 4 weeks before joining.
  • People who received any immune cell therapy within 3 months before joining.
  • People whose blood tests show a positive reaction to a specific component used in the trial's cell treatment (anti-CD19 scFv).
  • People who participated in another clinical trial within 4 weeks before joining.
  • People with uncontrolled infections or serious illnesses, including HIV, active hepatitis B or C, heart failure, unstable heart conditions, or other conditions the treating doctor considers a significant unpredictable risk.
  • People with large uncontrolled fluid build-up in body cavities, such as around the lungs or in the abdomen.
  • People who have had a stroke or bleeding in the brain within 3 months before joining.
  • People who had major surgery or a serious injury within 28 days before joining, or whose recovery from such events is not yet complete.
  • People who received donor cell therapy (such as donor lymphocyte infusion) within 6 weeks before joining.
  • People with a known allergy to any ingredient used in the trial's cell treatment product.
  • People with mental or physical conditions that, in the treating doctor's view, would prevent them from cooperating with the trial or would affect the reliability of the results.
  • People who are unable or unwilling to sign the informed consent form.
  • People considered unsuitable by the trial investigators for any other reason.

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 14 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: Weidong Han, Ph.D, Biotherapeutic Department, Chinese PLA General Hospital

Phone: +86-010-55499341

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
Chinese PLA General Hospital
Registry
ClinicalTrials.gov
Start date
11 December 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Phase 1: Incidence of Adverse Events (AEs); Phase 1: Incidence of Dose-Limiting Toxicities (DLTs); Phase 1: Recommended Phase 2 Dose (RP2D); Phase 2: Best Objective Response Rate; Phase 2: Best Complete Response Rate

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: 14 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