CAR-T plus autologous stem-cell transplant for relapsed or high-risk large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhengjiang, China Recruiting

Study contacts

• Study coordinator: Xi Chen
• Email: zjuchenxi@126.com
• Phone: +8617816890591

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.