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Recruiting Phase 1 / Phase 2

A Phase Ib/II Exploratory Clinical Trial of Memory-Enhanced 7×19-THEMIS CAR-T Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma

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About this study

This study is aimed to explored the safety and efficacy of 7×19-THEMIS CAR-T cell therapy for large B-cell lymphoma and to conduct an exploratory comparison of the 3-month objective response rate (ORR) and complete remission rate (CR rate) between the experimental cohort and the historical control cohort (NCT04833504).

Condition
Relapsed/Refractory Large B-cell Lymphoma (LBCL), Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Transforming Follicular Lymphoma (tFL), Mantle Cell Lymphoma (MCL)
Tested
7×19-THEMIS CAR-T cells
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Relapsed/Refractory Large B-cell Lymphoma (LBCL), Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Transforming Follicular Lymphoma (tFL), Mantle Cell Lymphoma (MCL)
  • Voluntarily participate in this study and sign the informed consent form.
  • Age range: 18 - 75 years old. Gender is not restricted.
  • Histologically confirmed large B-cell lymphoma, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL), and mantle cell lymphoma (MCL).
  • CD19-positive (as determined by immunohistochemistry or flow cytometry; based on the most recent tumor biopsy results).
  • Definition of relapsed/refractory: Failure to achieve complete remission (CR) after at least two lines of therapy (which must include a CD20 monoclonal antibody and an anthracycline); or disease progression during any course of treatment; or relapse/progression within 12 months after autologous hematopoietic stem cell transplantation.
  • At least one measurable lesion: any lymph node lesion with a longest dimension \>1.5 cm, or any extranodal lesion with a longest dimension \>1.0 cm, and the lesion shows uptake on PET-CT (SUV greater than the hepatic pool).
  • Absolute neutrophil count in peripheral blood ≥ 1,000/μL; platelet count ≥ 45,000/μL.
  • Cardiac, hepatic, and renal function: creatinine \< 1.5 mg/dL; ALT/AST ≤ 2.5 times the upper limit of normal; total bilirubin \< 1.5 mg/dL; ejection fraction ≥ 50%.
  • Possess sufficient cognitive capacity to voluntarily sign the informed consent form.
  • Participants of reproductive potential must be willing to use effective contraception (from the time of signing the informed consent form until 12 months after CAR-T infusion).
  • The investigator estimates a life expectancy of at least 4 months.
  • Willing to comply with the schedule of visits, dosing regimen, laboratory tests, and other trial procedures.

Exclusion 9

  • History of other malignant tumors (excluding cured basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, etc.).
  • Autologous hematopoietic stem cell transplantation within the past 6 weeks.
  • Any targeted CAR-T therapy within 3 months prior to this CAR-T treatment.
  • Patients who have previously received PD-1 monoclonal antibodies must have a washout period of ≥3 months before enrollment.
  • Received cytotoxic drugs, glucocorticoids (except for prednisone-equivalent doses of ≤10 mg/day), or other targeted therapies within 2 weeks prior to cell collection.
  • Active autoimmune diseases (e.g., systemic lupus erythematosus, inflammatory bowel disease, etc.).
  • Uncontrolled active bacterial, fungal, or viral infections.
  • HIV infection, syphilis; active hepatitis B or C: Hepatitis B: HBsAg-positive and HBV-DNA ≥ 1,000 IU/mL; Hepatitis C: HCV RNA-positive and abnormal liver function.
  • Known central nervous system lymphoma (confirmed by brain MRI or CT and cerebrospinal fluid examination).

Where

1 site, 1 recruiting

The Second Affiliated Hospital,School of Medicine,Zhejiang University, Hangzhou, Zhejiang 310009

Hangzhou, Zhejiang, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.