Single-center, single-arm study for autologous fully humanized CD22-CAR T cells in the treatment of refractory / relapsed acute B lymphoblastic leukemia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000028793

Enrollment

Unknown

Registered

2020-01-04

Start date

2020-01-02

Completion date

Unknown

Last updated

2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood disease

Interventions

Case series:CD22-CART cells

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as refractory / relapsed, patients with tumor surface antigen CD19 missing, relapsed after humanized CD22-CAR T treatment, full expression of CD22 or relapsed / refractory acute B lymphocytic leukemia over 100 days after allogeneic hematopoietic stem cell transplant ; 2. Male or female patients aged 1-18 years; 3. No severe allergies; 4. ECOG score 0-2 points; 5. Expected survival time >=60 days; 6. CD22 positive in bone marrow or peripheral blood or immunohistochemistry; 7. A self-knowledgeable 18-year-old patient voluntarily signs the informed consent form, and the legal representative (guardian) of a child patient under 18 years old voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or cerebral conscious disturbance; 2. Symptomatic heart failure or severe arrhythmia; 3. Symptoms of severe respiratory failure; 4. With other types of malignant tumors; 5. diffuse intravascular coagulation; 6. Serum creatinine and / or urea nitrogen = 1.5 times the normal value; 7. Suffering from sepsis or other uncontrollable infections; 8. suffering from uncontrollable diabetes; 9. severe mental disorders; 10. Skull MRI showed obvious lesions in the skull; 11. Cerebrospinal fluid examination of leukemia cells> 20 / ul; 12. The proportion of blood leukemia cells is> 30%; 14. Have received an organ transplant; 15. Positive blood HCG test for female patients (patients with fertility); 16. Hepatitis (including Hepatitis B and Hepatitis C), HIV / AIDS and syphilis screening.

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicity;Incidence and severity of treatment-related adverse events;Other safety observation indicators are vital signs, 12-lead ECG and clinical laboratory test results;	—

Secondary

Measure	Time frame
Proliferation and survival of CD22-CAR T cells in the blood of the subject;Objective response rate;Complete response rate;Partial response rate;Duration of remission;Progression-free survival;Total survival;	—

Countries

China

Contacts

Public ContactJing Pan

Beijing Boren Hospital

panj@borenhospital.com+86 18911067969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026