Status:
RECRUITING
Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma
Lead Sponsor:
Zhujiang Hospital
Conditions:
Relapsed/Refractory Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety of early secondary infusion of CD19 CAR T-cell therapy in adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), ...
Detailed Description
The goal of this clinical trial is to evaluate the efficacy and safety of early secondary infusion of CD19 CAR T-cell therapy in adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), ...
Eligibility Criteria
Inclusion
- Age ≥18 years, regardless of gender.
- Life expectancy \>12 weeks.
- ECOG performance status 0-2.
- Histologically or cytologically confirmed B-cell non-Hodgkin lymphoma per WHO 2016 classification, including:
- Diffuse large B-cell lymphoma (DLBCL) Primary mediastinal large B-cell lymphoma (PMBCL) Transformed follicular lymphoma (TFL) High-grade B-cell lymphoma (HGBCL).
- Relapsed/refractory disease, defined as:
- ≥1 prior relapse, Failure to achieve partial response (PR) after 2-3 cycles of first-line therapy, Failure to achieve complete response (CR) after 4-6 cycles of first-line therapy, Primary refractory disease, Secondary refractory disease, Disease progression following last line of therapy.
- Adequate venous access for leukapheresis, with:
- Hemoglobin ≥80 g/L, Absolute neutrophil count ≥1.0 ×10⁹/L, Platelet count ≥75 ×10⁹/L, OR parameters not meeting above thresholds but deemed acceptable for mononuclear cell collection per investigator's judgment.
- ≥1 measurable lesion per Lugano 2014 response criteria.
- Organ function requirements:
- Renal: Serum creatinine ≤2×ULN OR creatinine clearance ≥40 mL/min (Cockcroft-Gault formula).
- Cardiopulmonary:
- Left ventricular ejection fraction (LVEF) \>50%, Baseline oxygen saturation \>92% on room air.
- Hepatic:
- Total bilirubin ≤2×ULN (≤5×ULN in Gilbert syndrome), ALT/AST ≤3×ULN (≤5×ULN in patients with hepatic involvement).
- Negative serum pregnancy test for women of childbearing potential (WOCBP). Postmenopausal (≥2 years since last menses) or surgically sterilized women are exempt.
- Within 60 days post-axi-cel:
- Persistent ctDNA(+) or ctDNA(-→+) under CR or PET/CT-confirmed PR
Exclusion
- History of malignancies other than DLBCL, PMBCL, TFL, or HGBCL within 5 years prior to screening, except:
- Adequately treated carcinoma in situ of the cervix, Basal cell or squamous cell carcinoma of the skin, Localized prostate cancer after definitive resection, Ductal carcinoma in situ of the breast after curative surgery, Thyroid cancer after radical treatment.
- Unstable systemic diseases, including but not limited to:
- Active infections (excluding localized infections), Unstable angina, Cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), Myocardial infarction (within 6 months prior to screening), Congestive heart failure (NYHA Class ≥III), Severe arrhythmia requiring pharmacologic management, Hepatic, renal, or metabolic disorders.
- Conditions affecting informed consent or protocol compliance:
- Physical or psychological disorders impairing the ability to provide written informed consent, Inability or unwillingness to comply with study requirements.
- Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following prior axi-cel therapy.
- Active, uncontrolled serious infections.
- Uncontrolled active comorbidities that preclude study participation.
- Other conditions deemed by the investigator to confer unacceptable risk or render the patient ineligible.
Key Trial Info
Start Date :
February 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06902012
Start Date
February 1 2027
End Date
August 1 2028
Last Update
March 30 2025
Active Locations (1)
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1
Zhujiang Hospital
Guangzhou, Guangdong, China, 510282