Skip to content

A clinical trial of anti-CD30 CAR-T cell therapy

An Open single center arm clinical study of Anti-CD30 CAR-T therapy for relapsed, refractory and high-risk CD30+ Lymphoproliferative diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-16009069
Enrollment
Unknown
Registered
2016-08-23
Start date
2016-08-23
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

CD30+ Lymphoproliferative diseases

Interventions

Sponsors

Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in the clinical trials and sign the informed consent; 2. to be aged 18 to 70 years, no gender limited; 3. Patients with CD30+ Lymphoproliferative diseases by pathology and histology, and have no effective treatment by now, including patients who are with relapsed disease after chemotherapy or hematopoietic stem cell transplantation (HSC); or patients are voluntary to accept anti-CD30 CAR-T therapy as the salvage therapy; 4. types of CD30+ Lymphoproliferative diseases : (1) Adult T-cell leukemia/lymphoma; (2) ALCL; (3) AITL; (4) NK/T-cell lymphoma; (5) PTCL; (6) Enteropathy-associated T cell lymphoma; (7) Burkitt lymphoma; (8) Hodgkin lymphoma; (9) DLBCL; (10) Follicular lymphoma; (11) Primary mediastinal large B-cell lymphoma; (12) Mycosis fungoides; (13) Other CD30+ Lymphoproliferative diseases. 5. Patients enrolled in are meeting the following criteria: (1) Present residual disease after main therapy but not eligible for HSCT; (2) Relapse after CR1 but not eligible for HSCT; (3) Patients with high risk factors; (4) Failure to achieve remission or relapse after HSCT; (5) Patients with measurable lesions; 6. With observable tumor foci; 7. Multiple organ function assessment: Creatinine =95%; Bilirubin 40%; 8. Without history of accepting anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy(immune suppressive drugs treatment) within 4 weeks of screening; 9. Adequate venous access for apheresis; 10. ECOG score =3 months.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and nursing females; 2. Planning pregnancy within 1 year; 3. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening; 4. Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening; 5. active HBV/HCV infected; 6. any human immunodeficiency virus (HIV) infection; 7. History of accepting systemic steroids treatments within 4 weeks; 8. Allergic to any cytokines or antibodies; 9. Participation in an investigational research study within 6 weeks before enrolled; 10. History of accepting systemic steroids treatments within 4 weeks; 11. History of mental disorders; 12. Drug abuse and addiction; 13. Other situations we think improper for the research.

Design outcomes

Primary

MeasureTime frame
Safety;

Countries

China

Contacts

Public ContactZhou Jian-feng

Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

zhougene@medmail.com.cn+86 027-83662680

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026