NCT07503353

A Phase 1/2 Study of T-cell Expressing a Novel CD19 Chimeric-Antigen Receptor (SHB-02-CD19) in Patients With CD19-expressing B-cell Malignancies

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 1 Year – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II trial of SHB-02-CD19, T-cell expressing an anti-CD19 Chimeric-Antigen-Receptor (CAR) in patients with CD19 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed/refractory B-cell malignancies.

Detailed description

B-cell precursor Acute Lymphoblastic Leukemia (ALL) is the most common pediatric cancer, and an adult malignancy with poor prognosis. B-cell non-Hodgkin lymphoma (NHL) and common lymphocytic leukemia (CLL) arise from mature B-cells, and are more commonly seen in the adult and elderly population. In the recent decade, advances in immunotherapy targeting cell surface markers, using antibodies, antibody-drug conjugates, bispecific antibodies or CAR-T cells, have improved the outcome of patients with relapsed and refractory B-cell malignancies. CAR-T cell products targeting CD19, a common B-cell antigen, are approved for B-cell malignancies. Treatment with CD19 CAR-T cells was FDA approved for pediatric ALL, adult ALL, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, mantle-cell lymphoma (MCL) and primary mediastinal B-cell lymphoma (PMBCL). Still, most patients with B-cell malignancies treated nowadays with commercial CD19 CAR T-cells relapse. In this trial, patient will be treated with SHB-02-CD19, a novel CAR-T treatment manufactured by the Advanced Biotherapy Center (ABC) at the Sheba Medical Center, that uses a different construct than the commercial CAR-T products. The SHB-02-CD19 has a unique mutation in the CAR signaling domain, which is expected to improve efficacy while reducing toxicities, meaning this product is expected to have better clinical results at lower cell doses compared to the conventional CD19 CAR-T therapies. Patients will undergo a one-time cell collection via apheresis, after which the cells will be sent to the laboratory for activation and introduction of a gene that encodes a CAR which recognizes the CD19 antigen. Patients will receive lymphodepleting chemotherapy followed by a single dose of SHB-02-CD19, after which they will be monitored and undergo various research assessments (including blood tests and assessments of the disease status). Patients will be closely monitored for approximately 3 months after treatment to assess response and safety of the treatment. Long-term survival monitoring will take place once a year for 15 years.

Conditions

• B Cell Malignancies
• Acute Lymphobkastic Leukemia
• Non-Hodgekin Lymphoma (NHL-both Follicular & Diffuse Large Cell)

Interventions

Type	Name	Description
DRUG	SHB-02-CD19 (anti CD19 CAR-T cells)	Phase 1 of this study includes a dose escalation plan of SHB-02-CD19. Treatment will start at dose level 1. According to safety assessments, dose will increase to next dose level. Dose level 1: 0.25x10\^6 CAR+ T cells per kilogram Dose level 2: 0.5x10\^6 CAR+ T cells per kilogram Dose level 3: 1x10\^6 CAR+ T cells per kilogram Phase 2 of this study will be a dose expansion phase of the dose recommended based on safety and expected efficacy.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2030-01-01
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: Israel