Early Phase 1 Lymphoma Trial, Recruiting
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 a specific type of blood cancer called CD5-positive T-cell Acute Lymphoblastic Leukemia (CD5+T-ALL), according to recognised clinical guidelines.
- People whose cancer has come back or has not responded to treatment, meaning: the cancer did not go into remission after standard chemotherapy; or remission lasted 12 months or less; or the cancer has not responded to one or more follow-up treatments; or the cancer has come back multiple times.
- People whose cancer cells show a CD5 protein expression rate of more than 90% (a lab measurement from cancer cell testing).
- People whose bone marrow testing shows a certain level of abnormal (blast) cells — more than 5% under a microscope, and/or more than 1% by a specialised cell-counting method.
- People whose liver function and kidney function blood tests fall within the accepted ranges for this trial (confirm specific values with trial site).
- People whose heart pumping function (measured by an ultrasound called an echocardiogram) shows the heart is working at 50% or above.
- People whose blood oxygen level, measured by a pulse oximeter, is 92% or higher.
- People with an estimated life expectancy of at least 12 weeks.
- People with a general health and activity level score of 0, 1, or 2 on the ECOG scale — meaning they are able to carry out at least some daily activities (confirm with trial site).
- Women who are pregnant or breastfeeding, or any person of childbearing potential, who is willing to use effective contraception during the study and for at least 6 months after the last cell treatment.
- People who voluntarily agree to participate and provide written informed consent.
Who may not be able to join:
- People with a history of epilepsy or other conditions affecting the brain or nervous system.
- People with a prolonged QT interval (a specific heart rhythm measurement) or serious heart disease.
- People with an active hepatitis B, hepatitis C, or hepatitis E infection.
- People with an active infection that has not been successfully treated.
- People who have previously received any type of gene therapy product.
- People who have received certain treatments too close to the time of the trial infusion, including: systemic steroid medicines within the past 72 hours (except low-dose replacement steroids); certain targeted cancer medicines within the past 72 hours; systemic chemotherapy within the past 2 weeks (except specific preparatory treatment); or radiotherapy within the past 4 weeks.
- People whose immune cells do not respond strongly enough in laboratory testing before the trial treatment is prepared (confirm with trial site).
- People whom the trial investigators judge to be unsuitable for participation for any reason.
- People in any situation that investigators believe could increase risk or affect the reliability of the trial results.
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.
Contact this trial
Principal Investigator: He Huang, MD, First Affiliated Hospital of Zhejiang University
Phone: 057187233772
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
Where this trial is recruiting
Primary endpoints
Dose-limiting toxicity (DLT); Incidence of treatment-emergent adverse events (TEAEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.