Skip to content

An open-label, single-center and single-arm clinical study for sequential infusion of anti-CD22 and anti-CD19 CAR-T cells for patients with relapsed or refractory B-cell malignancies

An open-label, single-center and single-arm clinical study for sequential infusion of anti-CD22 and anti-CD19 CAR-T cells for patients with relapsed or refractory B-cell malignancies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-16008526
Enrollment
Unknown
Registered
2016-05-24
Start date
2016-05-25
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

B-cell malignancies

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 CD19+, CD22+ leukemia or lymphoma 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 through infusion of anti-CD19 CAR-T and anti-CD22 CAR-T cell therapy 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; (5) Patients with measurable lesions; 6. With observable tumor foci; 7. Multiple organ function assessment: Creatinine =95%; Bilirubin 40%; 8. Adequate venous access for apheresis; 9. 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 ContactJianfeng Zhou

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

zhougene@medmail.com.cn+86 027-83663609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 31, 2026