Skip to content

Phase I study of autologous anti-CD19 chimeric antigen receptor T cells treating refractory or relapsed B acute lymphoblastic leukemia

Phase I study of autologous anti-CD19 chimeric antigen receptor T cells treating refractory or relapsed B acute lymphoblastic leukemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020639
Enrollment
Unknown
Registered
2019-01-11
Start date
2019-01-02
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Relapsed or refractory B acute lymphoblastic leukemia

Interventions

Sponsors

Dongguan Taixin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with relapsed leukemia during chemotherapy or with primary drug resistance leukemia who have been diagnosed as CD19+ B-cell acute lymphoblastic leukemia(> 99% of leukemia cells express CD19)(In line with NCCN,2015.2), or patients with hematologic relapse after drug withdrawal who can't achieve CR after 1 cycle of chemotherapy; 2. Aged 1 to 70 years; 3. Patients with self-awareness and older than 18 years, who have the ability to sign the consent form and voluntary consent; 4. Pediatric patients' legal guardians or the clients authorized by patients sign the consent form and are voluntary to participate in the clinical trials.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or unconsciousness; 2. Symptomatic heart failure or severe cardiac arrhythmia; 3. Respiratory failure; 4. With other types of malignant tumors; 5. Disseminated intravascular coagulation; 6. Serum creatinine and/or urea nitrogen=1.5 ×normal; 7. Sepsis or other uncontrolled active infection; 8. Uncontrolled diabetes; 9. Severe mental disorder; 10. Obvious intracranial lesions examined by head MRI; 11. Cerebrospinal fluid leukemia cells> 20/ul; 12. Ratio of blood leukemia cell > 30%; 13. WHO physical status classification level=3; 14. Organ transplant recipients; 15. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
safety;Ratio of bone marrow and peripheral B leukemia cells;

Countries

China

Contacts

Public ContactChunfu Li

Dongguan Taixin Hospital

dongq@borenhospital.com+86 18675865379

Outcome results

None listed

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