Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Topcel-KH Pharmaceutical Co., Ltd.

About this trial

The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.

Eligibility criteria

Qualifiers

1. Subjects voluntarily participate in clinical research and sign informed consent.

2. Adult subjects (age ≥18 ) with relapsed or refractory diffuse large B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).

3. Expected survival ≥ 3 months.

4. At least one measurable lesion as per revised IWG response criteria for malignant lymphom (2014 Lugano criteria).

Disqualifiers

1. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.

2. Infectious disease(HIV, Active Tuberculosis ect.).

3. Active infection: hepatitis B, hepatitis C.

4. Abnormal vital signs or refuse to receive examination.

Trial design

Treatments tested in this trial

  • Anti-PD1 armored CD19 CAR-T cells

Treatment groups

30 Participants
are divided into 1 treatment group