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A single-center, open, non-randomized, single-arm clinical study of CD4-CART in the treatment of refractory and relapsed acute T lymphoblastic leukemia

A single-center, open, non-randomized, single-arm clinical study of CD4-CART in the treatment of refractory and relapsed acute T lymphoblastic leukemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042782
Enrollment
Unknown
Registered
2021-01-28
Start date
2021-01-26
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

Refractory and relapsed acute T lymphocytic leukemia

Interventions

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Acute T-lymphocytic leukemia (T-ALL) diagnosed as CD4 marker-positive, hematological recurrence during chemotherapy, or recurrence or primary drug resistance after bone marrow transplantation, or hematological recurrence after drug withdrawal (standard reference NCCN, 2015.2); 2. Aged 1-70 years; 3. Morphological examination of primitive and naive lymphocytes = 18 years of age are self-aware and able to sign informed and voluntary consent forms; The guardian of the pediatric patient or the patient's entruster signed the informed and voluntary consent form to join the trial.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or unconsciousness; 2. Symptomatic heart failure or severe arrhythmia; 3. Respiratory failure; 4. With other types of malignant tumors; 5. CD4-negative hematological tumors; 6. Diffuse intravascular coagulation; 7. Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 8. Sepsis or other infections that are difficult to control; 9. Uncontrollable diabetes; 10. Severe mental disorder; 11. There are obvious lesions in the skull by MRI of the head; 12. Cerebrospinal fluid examination for leukemia cells > 20/ul; 13. The proportion of blood leukemia cells > 30%; 14. WHO physical status classification >= 3; 15. Organ transplant recipients; 16. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Safety evaluation index;Pharmacokinetic evaluation index;Curative effect evaluation index;

Countries

China

Contacts

Public ContactDefeng Zhao

Beijing Boren Hospital

zhaodf@gobroadhealthcare.com+86 18601903811

Outcome results

None listed

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