NCT04661020 CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
| NCT ID | NCT04661020 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang University |
| Condition | Large B-Cell Lymphoma (LBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-12-03 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2020-12-03 with a primary completion date of 2026-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: 1. Age no less than 18, no gender limit; 2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified; 3. Confirmed CD19 and CD20 postive expressions in lymphoma cells 4. ECOG score 0-2; 5. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 6. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 7. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; 8. Estimated survival time ≥ 3 months; 9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: 1. Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 4. Active infection of hepatitis B virus or hepatitis C virus; 5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 6. Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ; 7. Other uncontrolled diseases that were not suitable for this trial; 8. Patients with HIV infection; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04661020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Large B-Cell Lymphoma (LBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04661020 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04661020 currently recruiting?
Yes, NCT04661020 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT04661020 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04661020 clinical trial?
NCT04661020 is sponsored by Zhejiang University. The trial plans to enroll 40 participants.