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

Summary

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

Inclusion Criteria:

* Patient must have a CD22-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy including CD19-directed therapy (For CD19 positive disease):
* 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
* 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
* At least 30 days after prior CAR therapy in absence of response

Conditions2

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