Phase 2 Lymphoma Trial, Recruiting NCT05768529 Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05768529
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 who are willing to sign a consent form and are able to follow the study requirements
  • People aged 18 to 70 years, of any gender
  • People diagnosed with a type of B-cell non-Hodgkin's lymphoma that tests positive for a protein called CD20, specifically: Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B Cell Lymphoma (PMBCL), Follicular Lymphoma that has transformed into Large B Cell Lymphoma (TFL), or High Grade B Cell Lymphoma (HGBCL)
  • People who have already received at least two rounds of treatment, or have had a stem cell transplant using their own cells (ASCT), including treatment with a specific type of chemotherapy drug (anthracycline) and a CD20-targeting drug such as rituximab
  • People whose lymphoma has either come back after a period of improvement, or has not responded adequately to previous treatments (confirm details with trial site)
  • People who have at least one area of lymphoma that can be measured on a scan, according to standard criteria
  • People who are generally well enough to carry out light activity and care for themselves (rated 0 or 1 on a standard fitness scale used in cancer care)
  • People whose blood counts meet minimum levels: enough neutrophils (a type of immune cell), lymphocytes (another immune cell type), and platelets (confirm exact values with trial site)
  • People whose liver, kidney, and lung function fall within acceptable ranges as determined by blood tests and oxygen levels (confirm exact values with trial site)
  • People who are not pregnant at the time of treatment, and who agree to use effective contraception throughout the study and for at least one year after receiving the trial treatment (applies to anyone who could become pregnant or father a child)
  • People whose T cells (a type of immune cell used in this therapy) are found to be functioning well enough
  • People whose veins are suitable for the blood collection procedure required before treatment
  • People who have not received a CD20-targeted antibody treatment for at least 3 months before receiving the trial treatment
  • People with a life expectancy of more than 3 months

Who may not be able to join:

  • People who have or have had another type of cancer, unless they have been cancer-free for more than 3 years, or the other cancer was a very early-stage, non-spreading type
  • People whose lymphoma has spread into the chambers of the heart
  • People who have used immune-suppressing medications, steroids (taken throughout the body), or high-dose chemotherapy within 2 weeks before signing the consent form, or who plan to use these before the blood collection procedure (local or inhaled steroids may be acceptable — confirm with trial site)
  • People who test positive for certain infections, including active Hepatitis B, active Hepatitis C, syphilis, HIV, or who have detectable levels of Epstein-Barr virus (EBV) or cytomegalovirus (CMV) in the blood
  • People with a current bacterial, fungal, viral, or other infection that the study doctor considers difficult to control
  • People with lymphoma that is currently active in the brain or spinal cord (central nervous system)
  • People with a current or past condition affecting the brain or nervous system, such as epilepsy, stroke, bleeding in the brain, dementia, or autoimmune conditions involving the nervous system
  • People who have had a heart procedure (such as a stent or angioplasty) within the past 12 months, or who have a history of heart attack, unstable chest pain, or other significant heart conditions as judged by the study doctor
  • People whose lymphoma is causing a medical emergency due to blockage or pressure on nearby structures, as judged by the study doctor
  • People who have previously received a CAR-T cell therapy that targeted the CD20 protein
  • People with a condition where the immune system does not work properly from birth (primary immunodeficiency)
  • People with a known allergic reaction to any ingredient used in the trial treatment
  • People who have received a live vaccine within 6 weeks before the screening visit
  • People who are pregnant or currently breastfeeding
  • People with an autoimmune disease that is currently active
  • People who currently have active graft-versus-host disease (a complication that can occur after receiving someone else's stem cells)
  • People who received a stem cell transplant using donor cells within the past 6 months
  • People who have taken part in another clinical trial within the past 30 days
  • People who the study doctor believes are not suitable 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

Phone: 18721281671

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
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Registry
ClinicalTrials.gov
Start date
28 March 2023
Est. completion
31 December 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Types, frequency and severity of adverse events; Overall Remission Rate (ORR)

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