Study of assessment of the CAR cell therapy on pediatric patients with refractory acute lymphoblastic leukemia

Phase 1

Recruiting

• Conditions: Relapsing or refractory acute lymphoblastic leukemia.; Acute lymphoblastic leukemia, in relapse; C91.02

• Registration Number: IRCT20240529061945N1
• Lead Sponsor: Carayakhteh Tajhiz Azma Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

boys or girls 2-18 years old
Relapsing or refractory CD19+ B-ALL
Disease in bone marrow (Blast > 5 percent)
Able to withstand the apheresis process to produce a research product as determined by the researcher
Life expectancy more than 12 weeks as determined by the researcher
Lansky score (<16 yeras) or Karnofsky score (>16 years) more than 50 percent
At least 7 days have passed since the last chemotherapy, excluding maintenance chemotherapy
At least 7 days have passed since the last treatment with corticosteroids
At least 3 days have passed since using a tyrosine kinase inhibitor (TKI)
The patient or the patient's guardian/legal representative should sign the informed consent form for this study.
Having potential donor for stem cell transplantation

Exclusion Criteria

Presence of active malignancy other than the disease under study
Presence of chloroma and leukemic infiltration on MRI, or patients with significant neurologic symptoms (unless alternative therapies lead to neurologic stabilization)
History or presence of any CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema
Presence of active GVHD (acute GVHD grade 2-4 or chronic extensive), or receiving immunosuppressive therapy to treat or prevent GVHD within 4 weeks before entering the study
Radiation therapy within 14 days from the time of enrollment in the study
History of Anti-CD19 or Anti-CD20 therapy
Donor Lymphocyte Infusion (DLI) or other cellular therapies within 30 days prior to enrollment in the study
Acute severe active infection
Hepatic dysfunction
Renal dysfunction
Cardiac dysfunction

Study & Design

• Study Type: interventional
• Study Design: Not specified