CAR-T for R/R B-NHL (NCT03196830) | Clinical Trial Compass
CompletedPhase 2
CAR-T for R/R B-NHL
China168 participantsStarted 2017-06-01
Plain-language summary
This study is a single arm study to investigate the efficacy and safety of CAR-T targeted CD19/CD20/CD22/CD30 in relapse and refractory non-Hodgkin lymphoma patients. Ten patients will recruieted, admitted in hospital for 1 month for the CAR-T treatment and follow-up for at least 2 years.
Who can participate
Age range
6 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological detection confirmed CD19/CD20/CD22/CD30 postive non-Hodgkin lymphoma
* Recieved more than 2 lines of chemotherapy
* With contraindications of hematopoietic stem cell transplantation or relapse after hematopoietic stem cell transplantation
* Expected survival more than 3 months
* Karmofsky performance score ≤ 60, and ECOG ≥ 2.
* Enough organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT \< 2 × upper limitation of normal; SpO2 \> 92%
* CBC results: Hb ≥ 80g/L, ANC \> 1 × 10E9/L, Plt ≥ 50 × 10E9/L
* Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
* With measurable disease
* Written informed consent could be acquired
Exclusion Criteria:
* Received immunol suppression treatment or steroids in recent 1 week before recruitment
* Uncontrolled infection
* HIV positive patients
* Active HBV or HCV infection
* Women in pregnancy and lactation
* Refuse to conception control during treatment and 1 year after CAR-T infusion
* Uncured malignancies other than non-Hodgkin lymphoma
* Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma
* Inheritated immune deficiancy
* Severe heart disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate
Timeframe: One months after CAR-T cells were infused
Trial details
NCT IDNCT03196830
SponsorThe First Affiliated Hospital of Soochow University