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.