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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600116310

Enrollment

Unknown

Registered

2026-01-08

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Large B-cell lymphoma

Interventions

Experimental group:Treatment with ASCT combined with Axi-cel

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Histopathologically confirmed large B-cell lymphoma (DLBCL, HGBL, CNSL, PMBCL, tFL); 3. Must receive a first-line regimen containing CD20 monoclonal antibody and anthracycline drugs; 4. Possess one of the following clinical or molecular biological high-risk factors: a. Clinical high-risk factors: Failure to achieve PR after 4 cycles of first-line immunotherapy; or recurrence within 12 months after achieving CR; or recurrence after ASCT; or central nervous system invasion at the time of disease recurrence/progression b. Molecular biological high-risk factors: TP53 mutation; or HGBL with MYC and Bcl-2 rearrangement with or without Bcl-6 rearrangement; 5. ECOG score 0-2; 6. According to the investigator's assessment, the physical condition is suitable for receiving HDCT/ASCT and plans to receive the ASCT followed by CAR-T treatment regimen; 7. Liver and kidney function: Serum ALT/AST = 30 ml/min; 8. Ejection fraction of the heart >= 40%; 9. Expected lifespan >= 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received CD19-targeted therapy; 2. Patients with negative immunohistochemical CD19 result; 3. Patients with active HBV or HCV infection, defined as HBV-DNA or HCV-RNA levels above the normal upper limit, with or without liver function abnormalities; 4. Patients with uncontrollable infections, cardiovascular and cerebrovascular diseases, coagulation disorders or connective tissue diseases; 5. Patients with a history of HIV infection; 6. Pregnant or lactating patients.

Design outcomes

Primary

Measure	Time frame
One-year progression-free survival rate;	—

Secondary

Measure	Time frame
Best objective response rate;duration of remission;	—

Countries

China

Contacts

Public ContactYang Haiyan

Zhejiang Cancer Hospital

haiyanyang1125@163.com+86 571 88122192

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026