Early Phase 1 Lymphoma Trial, Recruiting NCT07162012 Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Condition: Lymphoma
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Early Phase 1 Lymphoma Trial, Recruiting

NCT07162012
Recruiting Early Phase 1

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 70 years, of any gender.
  • People who have a specific genetic marker called HLA-A*11:01 (a result from a blood or tissue test).
  • People who have been diagnosed with a type of lymphoma (a blood cancer) that tests positive for the Epstein-Barr virus (EBV), confirmed by a laboratory test of tumor tissue, and who also have a measurable amount of EBV in their blood.
  • People whose lymphoma type includes, but is not limited to, NK/T-cell lymphoma, peripheral T-cell lymphoma, or other related types.
  • People whose cancer has come back after previously going into full remission (relapsed), or whose cancer did not respond well enough to standard treatment (refractory), as defined by specific treatment response criteria.
  • People with relapsed or refractory peripheral T-cell lymphoma or NK/T-cell lymphoma who have already received at least one prior course of treatment — and for NK/T-cell lymphoma, this must have included a specific type of chemotherapy containing a drug called asparaginase (and radiotherapy for certain early-stage nasal cases).
  • People who have at least one area of cancer that is large enough to be measured on a scan (confirm with trial site for exact size requirements), or, in some cases, a significant number of cancer cells found in bone marrow testing.
  • People whose blood counts, liver, kidneys, heart, and clotting function all meet minimum health thresholds, as confirmed by lab tests (confirm with trial site for exact values).
  • People whose doctors estimate they are likely to survive for more than 3 months.
  • People who are well enough to carry out basic daily activities, as measured by a standard medical scale called the ECOG score of 0, 1, or 2 (meaning not completely bedridden or severely limited).
  • People who are not planning a pregnancy during the treatment period; women who could become pregnant must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after treatment ends.
  • People who are willing to take part, are able to give signed consent, can follow the study plan, and have a suitable vein in their arm for collecting blood cells.

Who may not be able to join:

  • People with a history of another type of cancer, unless it was a very early or minor skin or surface cancer, or another cancer that was fully treated with no return for at least 5 years (confirm with trial site).
  • People who have received cancer treatment — such as chemotherapy, radiotherapy, targeted therapy, or immunotherapy — within the last 4 weeks, or palliative radiotherapy within the last 2 weeks.
  • People who are currently pregnant or breastfeeding.
  • People with serious medical conditions such as dangerously high pressure in the brain, significantly reduced consciousness, respiratory failure, or a severe blood clotting disorder called DIC.
  • People with severe organ problems, including very poor heart function (NYHA class IV), severely reduced liver function (Child-Pugh class C), significantly reduced kidney function, or a resting blood oxygen level below 92%.
  • People with certain active infections, including active hepatitis B or C under specific test conditions, HIV, syphilis, active tuberculosis or a past history of active tuberculosis, or other serious infections currently requiring treatment.
  • People with active disease affecting the brain or central nervous system, such as cancer spread to the brain, brain infections, or conditions that require urgent treatment or high-dose immune-suppressing medications.
  • People who are currently taking steroid medications (such as prednisone) taken by mouth or injection, and who are expected to need them long-term during the study — or anyone who has received such steroids within 72 hours before the planned cell infusion (skin creams or inhalers are generally not included; confirm with trial site).
  • People who have a condition called graft-versus-host disease (GVHD) of a moderate or severe level, or who are currently taking medications to suppress the immune system.
  • People with a known history of severe allergic reactions to any medications or ingredients used in this study, or a history of allergy to a drug called tocilizumab.
  • People who have any other condition that the trial doctor considers would make participation unsafe or unsuitable.

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Phone: +86 18918029692

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Registry
ClinicalTrials.gov
Start date
20 September 2025
Est. completion
1 September 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose-Limiting Toxicity (DLT); Maximum Tolerated Dose (MTD); Recommended Phase 2 Dose (RP2D)

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