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Phase 1 Study of h20.19 CAR T Cells for B-Cell Malignancies

This study is testing a new treatment called h20.19 CAR T cells for people with B-cell malignancies (cancers of certain white blood cells) that have come back or not responded to previous treatments. The h20.19 CAR T cells are designed to target both CD20 and CD19 proteins on cancer cells. You might be eligible if you are between 18 and 80 years old and have a B-cell malignancy that has relapsed or is refractory. The main goal is to find the safest dose of h20.19 CAR T cells. This is a Phase 1 study, meaning it's an early-stage trial focused on safety, and it plans to enroll about 24 participants.

Study design
This is a Phase 1, single-arm, open-label study designed to evaluate the safety of h20.19 CAR T cells. It plans to enroll approximately 21 to 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The maximum tolerated dose is measured at 28 days after CAR-T cell infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07335328

Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

Not Yet Recruiting
PHASE1Ages 18–80InterventionalTreatment
Medical College of Wisconsin
~24 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:1 X 10^6 cells/kg2.5 X 10^6 cells/kgDose expansion: The maximum tolerated dose of CAR-T cells

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose
Measured over 28 days post CAR-T cell infusion

Conditions

B-cell Non Hodgkin Lymphoma

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NCT07335328

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nirav Shah, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Medical College of Wisconsin Cancer Center Clinical Trials Office
[email protected]
866-680-0505 · ext. 8900
Email the study team

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Eligibility criteria

Exclusion

Condoms (male or female) with or without a spermicidal agent.
Diaphragm or cervical cap with spermicide.
Intrauterine device (IUD).
Hormonal-based contraception. Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation, salpingectomy, and/or bilateral oophorectomy, or men who have documented azoospermia) are eligible without requiring the use of contraception.

What this trial measures

  • Maximum tolerated dose28 days post CAR-T cell infusion

    The maximum tolerated dose (MTD) is the highest dose of a drug or treatment that does not cause dose-limiting toxicities (DLTs). This trial will utilize a 3+3 design to determine the safe dose. Three patients are enrolled and treated at the starting (lowest) dose level. * 0 DLTs: If none of the three patients experience a DLT, the next cohort of three patients is treated at the next higher dose level. * 1 DLT: If one patient experiences a DLT, an additional three patients are enrolled at the same dose level (expanding the cohort to six patients total). * 2 or more DLTs: If two or more patients in a cohort of three (or two or more in an expanded cohort of six) experience DLTs, the MTD is considered to have been exceeded. The trial stops escalating and the previous dose level is defined as the MTD.