Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell Therapy of Relapsed/Refractory B-Cell Lymphoma

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAffiliated Hospital to Academy of Military Medical Sciences

About this trial

This is a single arm study to evaluate the safety and efficacy of Nanobody-Based CD19/CD20 Tandem Dual CAR-T-cell therapy for Relapsed/Refractory B-Cell Lymphoma

Eligibility criteria

Qualifiers

The subject has voluntarily signed the informed consent form with full consent, and is willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures

Lymphoma cells confirmed to express CD19 and/or CD20 antigen by immunophenotyping or histopathological immunohistochemistry

B-cell lymphomas include: aggressive B-cell lymphomas (LBCL, BL, MCL) and indolent B-cell lymphomas (CLL/SLL, FL, MZL, LPL, HCL)

Relapsed/refractory B-cell lymphoma: For patients with aggressive lymphoma, disease stable for ≤12 months or disease progression after achieving best response following at least first- and second-line pharmacotherapy; or disease progression or relapse within ≤12 months after autologous stem cell transplantation. For patients with indolent lymphoma, disease progression, relapse or transformation following at least three lines of prior therapy

Disqualifiers

Severe cardiac insufficiency with left ventricular ejection fraction < 50%

History of severe pulmonary function-impairing diseases

Concomitant other advanced malignant neoplasms

Concomitant severe infection that cannot be effectively controlled

Trial design

Treatments tested in this trial

  • CD19/CD20 Tandem Dual CAR-T

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations