A Phase 1/2 Study of T-cell Expressing an Anti-CD22 Chimeric-Antigen Receptor (SHB-04-CD22) in Patients With CD22-expressing B-cell Malignancies

ConditionB Cell Malignancies

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age1-80

SponsorSheba Medical Center

About this trial

This is a phase I/II trial of T-cell expressing an anti-CD22 Chimeric-Antigen-Receptor (CAR) in patients with CD22 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed/refractory B-cell malignancies.

Eligibility criteria

Qualifiers

Relapse following standard relapse protocol (2nd relapse), including CD19 CART.

Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy.

Age 1-80 years

CD22 expression shown by flow cytometry on at least 70% of leukemic blasts / lymphoma cells

Disqualifiers

None

Trial design

Treatments tested in this trial

CD22 CAR-T cells

Treatment groups

50 Participants

are divided into 1 treatment group

Sponsors and collaborators

Sheba Medical Center

Lead sponsor

Source ClinicalTrials.gov