RightFit
RecruitingPhase 1 / Phase 2

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

A Single-arm, Multicenter, Open-label, Phase I/II Trial of Allo-QuadCAR01-T, an Allogeneic CAR-T-cell Therapy Targeting CD19 and CD20, for the Treatment of Relapsed or Refractory B-cell Malignancies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 15 years
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will get one infusion after chemotherapy to prepare their body."
  • "About 160 patients will take part, and researchers will follow them for up to 15 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Allo-QuadCAR01-T, a treatment made from donor immune cells that targets two proteins on B-cell cancers. It is for adults whose B-cell lymphoma or chronic lymphocytic leukemia (CLL) has come back or has not responded after at least two treatments. Researchers will check its safety, find a dose, and see how well it works.

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. It targets two proteins, CD19 and CD20, to lower the chance of relapse and uses gene editing to make it safer. The trial has three parts: first to find a safe dose, then to confirm it, and finally to test how well it works in patients with diffuse large B-cell lymphoma (DLBCL). Patients will get one infusion after chemotherapy to prepare their body. The main goal is to check safety and see how many patients have a complete response by Week 13. About 160 patients will take part, and researchers will follow them for up to 15 years.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have B-cell non-Hodgkin lymphoma or CLL that has come back or has not responded to treatment.
  • Have received at least two courses of treatment for the cancer.
  • Can do daily activities with little or no help.
  • Have heart, liver, and kidneys that work well enough.
  • Have HLA-B and HLA-C tissue markers that match the donor cells.
  • Have no active infection that is not under control.

Who can't join

  • Cancer in the brain or spinal cord during the early dose-testing groups. Later groups may allow this with study sponsor approval.
  • CAR-T treatment within 3 months, severe blood cell problems after CAR-T, or past CAR-T treatment targeting both CD19 and CD20.
  • A transplant using your own stem cells within 3 months; any past donor stem cell or organ transplant; or certain transplant-related illnesses.
  • Certain active or recent infections, including hepatitis B or C, syphilis, or HIV. A history of HIV may be allowed with sponsor approval.
  • Certain immune system diseases or antibodies, recent serious heart or nerve problems, bladder bleeding, or severe allergies to study drugs.
  • Another cancer that could affect the study. Some treated, early-stage, or long-controlled cancers are allowed.
  • Recent cancer treatment, radiation, immune-suppressing drugs, live vaccines, or major surgery. Lasting side effects from earlier treatment may also rule you out.
  • Pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (5)

IL

RI

TN

TX