Study on Allo-QuadCAR01-T, a New CAR-T Therapy Using Donor Cells for Treating Difficult B-Cell Cancers

Inclusion Criteria

• Adults aged 18 years or older.
• Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL).
• Must have received at least two previous treatments.
• Able to carry out daily activities (ECOG performance status 0-1).
• Have good heart, liver, and kidney function.
• Must match with donor cells based on specific genetic markers (HLA B/C).
• No active uncontrolled infections.

Exclusion Criteria

• Active cancer involvement in the brain or spinal cord (CNS) for initial dose groups; may be allowed later with approval.
• Previous CAR-T therapy within 3 months or severe side effects from it.
• Recent autologous stem cell transplant within 3 months.
• Previous allogeneic stem cell or organ transplant.
• Previous therapy with dual CD19/CD20 CAR-T.
• Severe allergic reactions to trial drugs or similar medications.
• History of graft-versus-host disease (GvHD) or certain post-transplant disorders.
• Presence of specific autoantibodies or related autoimmune diseases.
• Other cancers that could interfere with the trial, except for:
  • Certain treated skin cancers or cervical carcinoma in situ
  • Low-grade, early-stage prostate cancer not needing treatment
  • Hormone therapy for non-metastatic breast cancer for at least 2 years
  • Any other cancer in remission for at least 2 years
• Active viral infection within a week of screening, or serious bacterial/fungal infection.
• Bladder inflammation with bleeding (hemorrhagic cystitis).
• Active neurological autoimmune diseases (e.g., multiple sclerosis, Guillain-Barré, ALS).
• Active or residual hepatitis B, hepatitis C, or syphilis.
• Active HIV. History of HIV may be eligible with approval if:
• Neurological disorders within 6 months (e.g., stroke, dementia, Parkinson's).
• Significant heart disease within 6 months (e.g., heart attack, stent, unstable angina).
• Primary immunodeficiency or autoimmune disease needing treatment within 1 year (unless stable and approved).
• Unresolved moderate or severe side effects from previous therapy (except mild nerve damage).
• Use of systemic immunosuppressants within 28 days.
• Last lymphoma/CLL treatment within 28 days or 5 half-lives.
• Major surgery within 14 days.
• Local radiation within 28 days.
• Live vaccination within 28 days.
• Pregnant or breastfeeding women.