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New treatment option for Lymphoma Diffuse Large B-cell
Official title Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
ClinicalTrials.gov ID: NCT07284433
What this study is testing
What is Allo-QuadCAR01-T?
Allo-QuadCAR01-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma diffuse large b-cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready to use, which can save time and reduce costs.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Providence, Rhode Island, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Ulm, Baden-Wurttemberg, Germany
- Erlangen, Bavaria, Germany
- Munich, Bavaria, Germany
- Marburg, Hesse, Germany
- Essen, North Rhine-Westphalia, Germany
- Dresden, Saxony, Germany
- Berlin, Germany
- Hamburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Evanston, Illinois, United States; Providence, Rhode Island, United States; Nashville, Tennessee, United States; Houston, Texas, United States; Ulm, Baden-Wurttemberg, Germany and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.