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

Inclusion Criteria

• Adults 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 2 prior lines of therapy.
• ECOG performance status 0-1 (able to carry out daily activities).
• Adequate organ function (heart, liver, kidneys).
• HLA B/C match with donor cells.
• No active uncontrolled infections.

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.