Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies

Exclusion Criteria

• •Active CNS involvement (including PCNSL) in dose escalation cohorts; may be allowed in later cohorts with Sponsor approval.
• •Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T.
• •Autologous stem cell transplant within 3 months.
• •Prior allogeneic stem cell transplant or solid organ transplant.
• •Prior therapy with dual CD19/CD20 CAR-T.
• •Severe hypersensitivity to trial agents or similar compounds.
• •History of GvHD or post-transplant lymphoproliferative disorder.
• •Presence of La/SS-B autoantibodies or related autoimmune diseases.
• •Other malignancy that may interfere with trial, except:
• •* Curatively treated basal/squamous skin cancer or cervical carcinoma in situ
• •* Low-grade, early-stage prostate cancer (Gleason ≤6, Stage 1-2) with no therapy needed
• •* Adjuvant endocrine therapy for non-metastatic breast cancer (≥2 years)
• •* Any other curatively treated malignancy in remission ≥2 years
• •Active viral infection within 1 week of screening, or serious bacterial/fungal infection.
• •Hemorrhagic cystitis.
• •Active neuro-autoimmune disease (e.g., MS, Guillain-Barré, ALS).
• •Active or residual HBV, HCV, or syphilis.
• •Active HIV. History of HIV may be eligible with Sponsor approval if:
• •Neurological disorders within 6 months (e.g., stroke, dementia, Parkinson's, cerebellar disease, CNS autoimmune disease).
• •Significant cardiac disease within 6 months (e.g., MI, stent, unstable angina).
• •Primary immunodeficiency or autoimmune disease requiring systemic treatment within 1 year (unless stable and Sponsor-approved).
• •Unresolved ≥Grade 2 non-hematologic toxicity from prior therapy (except neuropathy up to Grade 2).
• •Systemic immunosuppression within 28 days.
• •Last systemic lymphoma/CLL therapy (standard or investigational) 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.