A single arm study for PD1 Gene knock-down anti-CD19 CAR-T Cell Immunotherapy for Relapsed/ Refractory/High risk B Cell Malignancies

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800020306

Enrollment

Unknown

Registered

2018-12-23

Start date

2018-12-25

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

B Cell Malignancies

Interventions

Case series:PD1 Gene knock-down anti-CD19 CAR-T Cell Immunotherapy

Eligibility

Sex/Gender

All

Age

14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in the clinical trials and sign the informed consent; 2. Aged 14 to 70 years male and female; 3. Patients with CD19 positive B Cell Malignancies diagnosed 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 PD1 Gene knock-down anti-CD19 CAR-T Cell Immunotherapy as the salvage therapy; 4. types of B cell malignancy are included: B cell Acute lymphoblastic leukemia; Indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B cell lymphoma (DLBCL, BL, MCL); Multiple myeloma; 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; 6.Patients with measurable lesions; 7. Multiple organ function assessment:Aspartate transaminase-alanine transaminase ratio =95%; LVEF=40%; 8. Adequate venous access for apheresis; 9. ECOG score =2, Estimated survival =3 months.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and nursing females; 2. Planning pregnancy within 1 year; 3. No guarantee of effective contraception within 1 year; 4. With Uncontrollable infection at the time of screening; 5. active HBV/HCV infected; 6. Human immunodeficiency virus (HIV) infection; 7. History of Severe autoimmune or immunodeficiency diseases; 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 that is not suitable for the study judged by investigator.

Design outcomes

Primary

Measure	Time frame
Safety;	—

Secondary

Measure	Time frame
efficacy;	—

Countries

China

Contacts

Public ContactHong Cen

The Affiliated Tumor Hospital of Guangxi Medical University

cen_hong@163.com+86 13507711671

Outcome results

None listed

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