Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT07135466
Eligibility Criteria:
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
Exclusion Criteria:
* 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:
1. Patients should be off steroids for at least 2 weeks prior to apheresis
2. 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.
3. 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.
4. Radiation therapy should be completed at least 3 weeks prior to apheresis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
80 Years
Study:
NCT07135466
Study Brief:
Protocol Section:
NCT07135466