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Clinical study of the safety and efficacy of chimeric antigen receptor gene-modified T cells targeting CD207 in the treatment of relapsed/refractory Langerhans histiocytosis

Clinical study of the safety and efficacy of chimeric antigen receptor gene-modified T cells targeting CD207 in the treatment of relapsed/refractory Langerhans histiocytosis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060467
Enrollment
Unknown
Registered
2022-06-02
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Relapsed/refractory Langerhans histiocytosis

Interventions

experimental group:CD207 - CAR - T cells

Sponsors

Beijing GoBroad Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. For patients diagnosed with Langerhans histiocytosis, relapse during chemotherapy, or primary drug resistance, or relapse after drug withdrawal (stop all scheduled chemotherapy courses), and complete remission cannot be achieved after 1 course of chemotherapy; 2. Aged 3-65 years; 3. Predicted survival > 12 weeks; 4. ECOG physical status score 0-1 or KPS score > 80; 5. Adequate venous access for simple or intravenous blood collection and no other contraindications for blood cell separation; 6. WBC>=2.5x10^9/L, LY>=0.7x10^9/L, LY%>=15%; 7. Serum creatinine <=2.0mg/dL (176.8µmol/L); 8. ALT and AST<=2.5 ULN; 9. Serum total bilirubin <=2.0mg/dL (34.2µmol/L); 10. PT: INR < 1.7 or PT longer than normal < 4s; 11. The patient is self-aware, or the patient signs a power of attorney to authorize the entruster, and the guardian of the child patient signs an informed consent letter to join the study.

Exclusion criteria

Exclusion criteria: 1. Transduction-positive T lymphocytes were 300mg/d; Clopidogrel, dose > 75mg/d). 18. Radiotherapy was performed within 4 weeks prior to study initiation (blood collection). 19. Uncontrolled symptoms or other diseases include, but are not limited to, infections, congestive heart failure, unstable angina, arrhythmias, psychosis, or those that pose an unpredictable risk in the opinion of the attending physician. 20. Patients with severe acute allergic reactions. 21. Patients participating in other clinical trials. 22. The researchers did not consider clinical participants appropriate for other reasons.

Design outcomes

Primary

MeasureTime frame
Objective response rate;Incidence and severity of adverse reactions;

Secondary

MeasureTime frame
Progression-free survival;Overall survival;

Countries

China

Contacts

Public ContactLi Zhihui

Beijing GoBroad Boren Hospital

lizhih@gobroadhealthcare.com+86 15810887023

Outcome results

None listed

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