CAR-T plus autologous stem-cell transplant for relapsed or high-risk large B‑cell lymphoma
A Single-arm, Single-center, Open-label Clinical Study on the Efficacy and Safety of CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
This trial will try CAR-T cell therapy together with an autologous stem-cell transplant in adults whose large B‑cell lymphoma has relapsed or is refractory and who have high‑risk features.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 1 site (Hangzhou, Zhengjiang) |
| Trial ID | NCT07538635 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single‑arm, single‑center, open‑label Phase 2 trial testing axicabtagene ciloleucel given after autologous stem‑cell transplantation in adults with relapsed/refractory large B‑cell lymphoma and predefined high‑risk clinical or molecular features. Participants undergo leukapheresis and stem cell collection, may receive one course of bridging therapy if needed, then receive high‑dose conditioning (TB for CNS involvement or BEAM for others, with adjustments allowed for prior ASCT), followed by stem cell infusion on Day 0 and CAR‑T infusion on Days 4–7. The trial will track tumor response rates and durability as well as safety outcomes, including treatment‑related toxicities and transplant complications. All activities are conducted at Zhejiang Cancer Hospital in Hangzhou.
Who should consider this trial
Good fit: Adults (age ≥18) with histologically confirmed large B‑cell lymphoma subtypes who have relapsed/refractory disease and meet specified clinical high‑risk (early relapse, failure to achieve PR after frontline therapy, post‑ASCT relapse, or CNS involvement) or molecular high‑risk (for example, TP53 mutation or other high‑grade features) criteria are ideal candidates.
Not a fit: Patients without high‑risk features, those who are ineligible for autologous stem‑cell transplant or CAR‑T infusion because of poor organ function, uncontrolled infection, or other major comorbidities are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the combination could increase the chance of deeper and more durable remissions for high‑risk relapsed/refractory large B‑cell lymphoma patients.
How similar studies have performed: CAR‑T therapies have shown strong activity in relapsed/refractory LBCL, and early or exploratory reports of combining high‑dose therapy/ASCT with cellular therapies exist, but the sequential ASCT→CAR‑T approach is still relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhengjiang
- Zhejiang Cancer Hospital — Hangzhou, Zhengjiang, China (Recruiting)
Study contacts
- Study coordinator: Xi Chen
- Email: zjuchenxi@126.com
- Phone: +8617816890591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.