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

NCT07335328 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IIT-SHAH-CAR-H20-19
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B-cell Non Hodgkin Lymphoma

Keywords

CAR-T; Chimeric antigen receptor T-cell therapy; CAR Therapy

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  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.

  28 days post CAR-T cell infusion

Secondary Outcomes (7)

• Adverse Events

  Up to 2 Years post CAR-T cell infusion

• Overall Response Rate (ORR)

  28 days post CAR-T cell infusion

• Complete Response (CR) Rate

  28 days post CAR-T cell infusion

• Duration of Response (DOR)

  Up to 2 years post CAR-T cell infusion

• Relapse rate

  120 days; 1 year; 2 year post CAR-T cell infusion

Study Arms (3)

Dose Level 0: 1 X 10^6 cells/kg

EXPERIMENTAL

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

Biological: 1 X 10^6 cells/kg

Dose Level 1: 2.5 X 10^6 cells/kg

EXPERIMENTAL

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

Biological: 2.5 X 10^6 cells/kg

Dose Expansion: Maximum Tolerated Dose

EXPERIMENTAL

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.

Biological: Dose expansion: The maximum tolerated dose of CAR-T cells

Interventions

1 X 10^6 cells/kg BIOLOGICAL

Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.

Dose Level 0: 1 X 10^6 cells/kg

2.5 X 10^6 cells/kg BIOLOGICAL

Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.

Dose Level 1: 2.5 X 10^6 cells/kg

Dose expansion: The maximum tolerated dose of CAR-T cells BIOLOGICAL

Dose expansion: 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.

Dose Expansion: Maximum Tolerated Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Platelets ≥50,000 with no transfusion within 72 hours.
• Adequate renal function, defined as creatinine clearance ≥50 mL/min measured by CKD-EPI 2021 calculator OR 24-hour urine collection.
• Left ventricular ejection fraction of ≥45% -- by cardiac echocardiogram (ECHO) or Multigated Acquisition scan (MUGA) -- and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.
• Expected survival \>12 weeks.
• No contraindication to central line access.
• Patient has demonstrated compliance with prior therapies.
• Meet criteria for regarding fertility and contraception detailed below.

You may not qualify if:

• Positive beta human chorionic gonadotropin (hCG) test in female of child-bearing potential.
• 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:
• a. Patients with prior CNS disease that have been effectively treated will be eligible, provided treatment was \>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.
• 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.
• Anti-CD19 antibody treatment within 4 weeks of cell infusion.
• Cytotoxic chemotherapy other than lymphodepletion within 14 days of the lymphodepletion start date.
• Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR T cells.
• Oral chemotherapeutic agents or antibody-directed treatment within 7 days of apheresis:
• a. BTK inhibitors are allowed until 1 day prior to apheresis and can be restarted until 1 day prior to lymphodepletion.
• Patients post solid organ transplant who develop high-grade lymphomas or leukemias.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nirav Shah, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2031
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)