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Phase I study of sequential chimeric antigen receptor T cell therapy targeting at different B-cell antigens in primary refractory or chemotherapeutic relapsed B-cell acute lymphoblastic leukemia

Phase I study of sequential chimeric antigen receptor T cell therapy targeting at different B-cell antigens in primary refractory or chemotherapeutic relapsed B-cell acute lymphoblastic leukemia

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIB-17013670
Enrollment
Unknown
Registered
2017-12-04
Start date
2017-12-05
Completion date
Unknown
Last updated
2017-12-11

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

Conditions

primary refractory or chemotherapeutic relapsed B-cell acute lymphoblastic leukemia

Interventions

Sponsors

Beijing Boren Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Primary refractory or chemotherapeutic relapsed B-cell acute lymphoblastic leukemia (B-ALL) patients who have been diagnosed as CD19+/CD22+/CD20+ positive(> 99% of leukemia cells express CD19/CD22/CD20)(In line with NCCN,2015.2), without indications or aggrement of allogeneic hematopoietic stem cell transplantation (allo-HSCT); 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 ContactChunrong Tong

Beijing Boren Hospital

tongcr@borenhospital.com+86 13601301042/010-63290606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026