Status:
NOT_YET_RECRUITING
A Study of T-cell Expressing an Anti-CD22 Chimeric-Antigen Receptor in Patients With CD22 B-cell Malignancies
Lead Sponsor:
Sheba Medical Center
Conditions:
B Cell Malignancies
Eligibility:
All Genders
1-80 years
Phase:
PHASE1
PHASE2
Brief 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 pediatri...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Evidence of active Hepatitis B, Hepatitis C or HIV infection.
- Prior therapy:
- 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.
- Patients should have recovered from all toxicities attributed to prior therapy. Cytopenias that are considered disease related rather than therapy related are exempt from this exclusion.
- Radiation therapy should be completed at least 3 weeks prior to apheresis.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07135466
Start Date
November 1 2025
End Date
January 1 2028
Last Update
August 22 2025
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, G, Israel