CAR T-Cells for B-Cell Lymphoma

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical College of Wisconsin

Must not be taking: Anti-CD20, Anti-CD19, Chemotherapy, Steroids

Disqualifiers: HIV, Hepatitis B/C, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Nirav Shah, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Adults aged 18-80 with relapsed or refractory B-cell malignancies can join this trial. They must have a heart pumping capacity (ejection fraction) of at least 45%, good kidney function, no severe liver issues, and adequate blood counts without recent growth factor support. People with CNS involvement or suspected CNS disease at enrollment cannot participate.

Inclusion Criteria

My white blood cell count is healthy without recent strong medication.

I meet the basic requirements to participate in the trial.

I have had brain involvement or there's a current suspicion of it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive h20.19 CAR T cells with dose escalation to determine the maximum tolerated dose

4 weeks

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular visits for monitoring adverse events and response

Dose Expansion

Evaluation of h20.19 CAR T cells at the maximum tolerated dose in an expanded cohort

Varies based on cohort completion

What Are the Treatments Tested in This Trial?

Interventions

• h20.19 CAR T cells

Trial Overview

The trial is testing the safety of a new CAR T cell therapy targeting two proteins on B-cells (CD19 and CD20). Patients will receive one of two doses: either 1 million cells per kg or up to the maximum tolerated dose determined during the study.

How Is the Trial Designed?

Group I: Dose Level 1: 2.5 X 10^6 cells/kg Experimental Treatment 1 Intervention

The investigators will start at a dose of 1 X 10\^6 cells/kg and escalate based on the presence of toxicities.

Group II: Dose Level 0: 1 X 10^6 cells/kg Experimental Treatment 1 Intervention

The investigators will start at a dose of 1 X 10\^6 cells/kg and escalate based on the presence of toxicities.

Group III: Dose Expansion: Maximum Tolerated Dose Experimental Treatment 1 Intervention

The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10\^6 cells/kg or 2.5 X 10\^6 cells/kg. After completing the dose escalation cohort, the investigators will open a 12-patient dose-expansion evaluation of h20.19 CAR T cells.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+