Phase 2 Lymphoma Trial, Recruiting NCT05436223 Sponsor: Hrain Biotechnology Co., Ltd. Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05436223
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:

  • Adults aged 18 or older, of any gender, with a type of B-cell non-Hodgkin's lymphoma that has come back or stopped responding to treatment
  • People whose doctors estimate they are likely to live for more than 12 weeks
  • People with a general health status rated as reasonably functional (a standard medical scoring system rates this as 0–2, meaning the person can largely care for themselves — confirm with trial site)
  • People whose lymphoma has been confirmed by a tissue or cell sample as one of these specific types: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), or high-grade B-cell lymphoma (HGBCL)
  • People who meet at least one of the following treatment history conditions: (1) the lymphoma came back or stopped responding after standard first-line treatment and at least two rounds of second-line treatment, and prior treatment must have included drugs targeting CD20 and a type of chemotherapy called anthracyclines; or (2) the lymphoma came back after a stem cell transplant, regardless of what other treatments were received
  • People whose blood counts and veins are suitable for a cell collection procedure, with minimum levels of haemoglobin, white blood cells, and platelets meeting specific thresholds (confirm exact values with trial site)
  • People who have at least one measurable area of lymphoma that can be tracked using standard imaging guidelines
  • People whose kidney, liver, and heart and lung function meet specific minimum thresholds set by the trial, including adequate kidney function, heart pumping function above 50%, blood oxygen levels above 92%, and liver enzyme and bilirubin levels within acceptable ranges (confirm exact values with trial site)
  • People who are able to understand and sign a consent form agreeing to participate

Who may not be able to join:

  • People who have had a different type of cancer (other than the four lymphoma types listed above) within the past five years, unless it was a specific type that was fully treated, such as certain skin cancers, cervical cancer in situ, localised prostate cancer, ductal carcinoma in situ, or thyroid cancer — all after complete surgical removal
  • People with active hepatitis B, hepatitis C, HIV, or syphilis infections detected through blood tests
  • People with serious uncontrolled conditions such as active infections, uncontrolled chest pain, a stroke or mini-stroke within the past six months, a heart attack within the past six months, severe heart failure, serious heart rhythm problems requiring medication, or significant liver, kidney, or metabolic disease
  • People with any other serious uncontrolled medical condition that the trial team believes would make participation unsafe
  • People whose situation the trial investigators believe could put them at risk or interfere with the trial's goals
  • Women who are pregnant or breastfeeding, people planning a pregnancy during treatment or within one year after treatment, or male participants whose partner plans to become pregnant within one year after the cell infusion
  • People who have had an active or uncontrolled infection requiring full-body (systemic) treatment within the 14 days before joining the trial, except for straightforward urinary tract or upper respiratory infections
  • People who have been taking systemic steroid medications in the 14 days before joining and are expected to need them long-term during the trial (inhaled or topical steroids are generally acceptable — confirm with trial site), or people who have recently received any systemic anti-cancer treatment (other than localised treatments)
  • People who have previously received CAR-T cell therapy or any other gene-modified cell therapy
  • People who have symptoms affecting the brain or central nervous system from their lymphoma, or who have had brain or central nervous system treatment (such as radiotherapy or surgery) within the three months before joining
  • People who are unable or unwilling to follow the study procedures, or whose condition affects their ability to provide informed consent
  • People whom the trial investigators consider unsuitable for the trial 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 20 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: Peng Liu, M.D. & Ph.D., Shanghai Zhongshan Hospital

Phone: +8615811287219

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
Hrain Biotechnology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
9 August 2021
Est. completion
9 August 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall response rate (ORR) at 3 months post infusion

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: 20 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