NCT07538635 CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
| NCT ID | NCT07538635 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang Cancer Hospital |
| Condition | High-risk R/R LBCL |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2028-02-29 |
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 20 participants in total. It began in 2026-04-20 with a primary completion date of 2028-02-29.
⚠ 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
This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (tFL) 3. Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline 4. Meet one of the following clinical high-risk factors or molecular biological high-risk factors: 1. Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months after achieving complete response (CR) with first-line immunochemotherapy; or relapse after autologous hematopoietic stem cell transplantation (ASCT); or central nervous system involvement at the time of disease relapse or progression 2. Molecular biological high-risk factors: TP53 gene mutation; or high-grade B-cell lymphoma (HGBL) with MYC and Bcl-2 rearrangements, with or without Bcl-6 rearrangement 5. ECOG 0 to 2 6. Eligible for high-dose chemotherapy/autologous hematopoietic stem cell transplantation (HDCT/ASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy 7. Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 mg/dL; serum creatinine ≤ 1.5 × ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 30 mL/min 8. Left ventricular ejection fraction (LVEF) ≥ 40% 9. Life expectancy ≥ 3 months Exclusion Criteria: 1. Patients who have previously received any CD19-targeted therapy 2. Patients with CD19 negativity confirmed by immunohistochemistry (IHC) 3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with or without liver function abnormalities 4. Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases 5. History of human immunodeficiency virus (HIV) infection 6. Pregnant or lactating patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07538635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying High-risk R/R 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 NCT07538635 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 NCT07538635 currently recruiting?
Yes, NCT07538635 is actively recruiting participants. Contact the research team at zjuchenxi@126.com for enrollment information.
Where is the NCT07538635 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07538635 clinical trial?
NCT07538635 is sponsored by Zhejiang Cancer Hospital. The trial plans to enroll 20 participants.