Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Tongji Hospital, Tongji University School of Medicine

About this trial

This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.

In this study phase, a traditional "3+3" trial design is employed for dose escalation.

Eligibility criteria

Qualifiers

Voluntary participation in the clinical trial; the individual or legal guardian fully understands and consents to the study by signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.

Age between 18-70 years.

Patients who are refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and not suitable for other treatment options such as a second hematopoietic stem cell transplantation.

Relapse or refractory disease after two or more lines of systemic therapy

Disqualifiers

CD19-targeted therapy.

Use of chlorambucil or cladribine within 3 months prior to enrollment, or use of PEG-asparaginase within 3 weeks prior to enrollment.

Injection of live vaccines within 4 weeks prior to enrollment.

Donor lymphocyte infusion (DLI) within 28 days prior to enrollment.

Trial design

Treatments tested in this trial

  • anti-CD19-CAR-T cells

Treatment groups

12 Participants
are divided into 1 treatment group