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CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.

ConditionHigh-risk R/R LBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Cancer Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

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)

Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline

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

Disqualifiers

Patients who have previously received any CD19-targeted therapy

Patients with CD19 negativity confirmed by immunohistochemistry (IHC)

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

Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases

Trial design

Design model

Single group

Treatments tested in this trial

  • Axicabtagene Ciloleucel

    Biological/Vaccine

    R/R LBCL with high-risk factors sequentially undergo leukapheresis, stem cell collection, bridging therapy (if applicable, at the investigator's discretion, with only one course of bridging therapy allowed), preconditioning chemotherapy phase (for CNSL patients: TB regimen, carmustine 300 mg/m² on Day -6, thiotepa 10 mg/kg on Day -5 to Day -4; for non-CNSL patients: BEAM regimen, carmustine 300 mg/m² on Day -7, etoposide 150 mg/m² on Day -6 to Day -3, cytarabine 200 mg/m² on Day -6 to Day -3, melphalan 140 mg/m² on Day -2; for patients with prior autologous hematopoietic stem cell transplantation, the investigator may develop other preconditioning regimens based on factors such as the patient's drug sensitivity and tolerability), stem cell infusion (Day 0), and CAR-T cell infusion (Day 4 to Day 7). A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: CAR-T+ASCTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-year PFS rate

1-year progression-free survival rate

Time frame
From date of CAR-T infusion until the date of first documented date of disease progression or death from any cause, assessed up to 12 months

Secondary outcomes

1

bORR

Best objective response rate

Time frame
The best therapeutic effect within 12 months after CAR-T infusion was the proportion of subjects achieving complete remission (CR) or partial remission (PR).
2

DOR

Duration of response

Time frame
12 months after CAR-T infusion
3

PFS

Progression-free survival

Time frame
From date of CAR-T infusion until the date of first documented date of disease progression or death from any cause, assessed up to 12 months
4

OS

Overall survival

Time frame
From date of CAR-T infusion until the date of first documented date of death from any cause, assessed up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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