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

NCT07503353 | Not Yet Recruiting Phase 1

• 2 other identifiers: SHB-02-CD192757-25-SMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ALL; DLBCL; NHL; CAR-T; CD-19

Outcome Measures

Primary Outcomes (3)

• Safety Evaluation: Treatment Related Toxicities

  An evaluation of safety of the use of SHB-02-CD19 manufactured at the Sheba Medical Center, in patients with relapsed/refractory B-cell malignancies. Safety will be determined by evaluation of participants with treatment-related adverse events, as assessed by CTCAE 5.0.

  From enrollment to 3 months post treatment.

• Efficacy Evaluation

  An evaluation of the feasibility and efficacy of administering SHB-02-CD19 in patients with B-cell malignancies at the Sheba Medical Center. Efficacy will be determined by an evaluation of disease response in participants post treatment. Disease response will be assessed by blasts percentage and minimal-residual disease (MRD) in the bone marrow for ALL patients, and by PET-CT scan based on the Lugano classification for NHL patients.

  1 month to 1 year post treatment.

• Minimal toxic dose evaluation

  An evaluation of the minimal toxic dose of SHB-02-CD19. This will be determined by evaluation of participants with treatment-related adverse events, as assessed by CTCAE 5.0, and according to different dose levels administered.

  From first dose to end 3 months post treatment.

Study Arms (1)

Single arm, open label, dose escalation: SHB-02-CD19 (anti CD19 CAR-T)

EXPERIMENTAL

anti CD19 CAR-T cells

Drug: SHB-02-CD19 (anti CD19 CAR-T cells)

Interventions

SHB-02-CD19 (anti CD19 CAR-T cells) DRUG

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.

Single arm, open label, dose escalation: SHB-02-CD19 (anti CD19 CAR-T)

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have a CD19-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy and not eligible for current commercial CD19 CAR T cells per Israeli MOH health basket:
• Relapse following standard relapse protocol (2nd relapse)
• Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy.
• Patients who have histologically confirmed large B-cell lymphoma, according to the World Health Organization 2016 classification criteria, that are refractory to first-line treatment or that have relapsed from complete remission no more than 12 months after the completion of first-line chemo-immunotherapy including an anti-CD20 monoclonal antibody and anthracycline-containing regimen.
• Very high risk 1st relapse of ALL, defined as (a) relapse within 18 months of initial diagnosis; (b) relapse with the following cytogenetic abnormalities: KMT2a-R, TCF3::HLF, TCF3::PBX1, TP53-alterations.
• Age 1-80 years
• For ALL, CD19 expression shown by flow cytometry or immunohistochemistry on at least 70% of leukemic blasts.
• Adequate CD3 count (above 120 CD3+ cells per microliter blood)
• Clinical performance status: Patients \> 10 years of age: Karnofsky ≥ 50%; Patients ≤ 10 years of age: Lansky scale ≥ 50%. Exception for neurologic symptoms (e.g. paralysis) that are explained by the malignancy.
• Females of child-bearing potential must have a negative pregnancy test
• Cardiac function: LV ejection fraction \>45% or shortening fraction \>28%
• At least 60 days after autologous or allogeneic BMT
• No prior CD19 CAR T cell administered
• Prior therapy:
• Patients should be off steroids for at least 2 weeks prior to apheresis

You may not qualify if:

• Hyperleukocytosis (WBC\>50,000) or rapidly progressive disease that in the judgment of the PI can compromise the ability of the patient to complete the study
• Pregnant or breast-feeding females
• Hepatic dysfunction, defined as bilirubin \> x2 upper normal limit (except when explained by hemolysis or Gilbert) or SGOT \> x2.5 upper normal limit.
• Active HIV infection, HBV or HCV infection which is identified by positive PCR of viral sequences. Patients who are positive for HCV Abs, HBsAg and/or positive to HBcAbs total, will be evaluated by PCR of viral sequences. If PCR is positive, the patient will be excluded.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Central Study Contacts

Sivan Yakobi

CONTACT

972-03-5309046; sivan.yakobi@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Hematology and Oncology

Model Details: Single arm, open label, non-randomized trial

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)