Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refract… (NCT07335328) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies
United States24 participantsStarted 2026-09-01
Plain-language summary
This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must be aged ≥ 18 years and ≤80 years with relapsed or refractory B-cell malignancy.
. Absolute CD3 count ≥50 mm\^3.
. Magnetic resonance imaging (MRI) brain and lumbar puncture with cerebral spinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with:
. A history of CNS involvement OR
. A clinical suspicion at the time of enrollment.
. Karnofsky performance score ≥70.
. Adequate hepatic function, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \<3 × upper limit of normal (ULN); serum bilirubin \<2.0 mg/dL, or considered not clinically significant as per the clinical principal investigator's discretion (e.g., Gilbert's or indirect hyperbilirubinemia).
. Absolute Neutrophil Count (ANC) ≥1000 with no Granulocyte Colony-Stimulating Factor (G-CSF) within 72 hours or pegylated G-CSF within 14 days.
Exclusion criteria
. Positive beta human chorionic gonadotropin (hCG) test in female of child-bearing potential.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a CAR T cell therapy that targets two proteins at once — CD20 and CD19 — instead of just one; can you explain why targeting both might matter for my specific type of B-cell lymphoma, and whether that approach offers any potential advantage over single-target CAR T therapies I might already qualify for?
2Since this is a Phase 1 trial focused on finding the maximum tolerated dose, the primary goal is safety rather than proving the treatment works — so how would you weigh the unknown risk profile of this experimental therapy against standard treatment options available to me right now?
3The trial isn't recruiting yet, so there could be a significant wait before it even opens; given where my disease stands today, is waiting a realistic option, or would you recommend pursuing another treatment in the meantime?
4CAR T cell therapies generally require a hospital stay and can have serious side effects like cytokine release syndrome — what additional risks or unknowns should I be aware of with this being a brand-new, first-in-human bispecific CAR T approach?
5Are there other relapsed or refractory B-cell lymphoma trials or approved CAR T options I should compare this one against before deciding whether this trial is even worth pursuing when it opens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose
Timeframe: 28 days post CAR-T cell infusion
Trial details
NCT IDNCT07335328
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-05-01
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office
. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \>20 mg of prednisone or equivalent daily.
. Presence of Grade ≥3 non-hematologic toxicities per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 unless believed to be due to underlying disease.
. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. A minimum of 14 days or 5 half-lives of the drug, whichever is shorter, of washout is required prior to apheresis.
. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture:
. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \<100 days post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.
. Anti-CD20 antibody treatment within 4 weeks of cell infusion.