Not Yet RecruitingPhase 1/2

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

Israel50 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range1 Year – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Patients should be off steroids for at least 2 weeks prior to apheresis
✓. Patients should be off systemic anti-neoplastic treatment for 2 weeks prior to apheresis, with the exception of intrathecal chemotherapy. Patients who received prior clofarabine and fludarabine should have a wash out period of 3 months prior to apheresis.

Exclusion criteria

✕. Radiation therapy should be completed at least 3 weeks prior to apheresis.

What they're measuring

Safety Evaluation: Treatment Related Toxicities

Timeframe: From enrollment to 3 months post treatment.

Efficacy Evaluation

Timeframe: 1 month to 1 year post treatment.

Minimal toxic dose evaluation

Timeframe: From first dose to end 3 months post treatment.

Trial details

NCT IDNCT07503353

SponsorSheba Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2029-06

Contact for this trial

Sivan Yakobi

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

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