Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age14-70
SponsorShanghai First Song Biotechnology Co., LTD

About this trial

This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.

Eligibility criteria

Qualifiers

Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures.

Age ≥ 14 years and < 70 years.

No response to first-line treatment (primary refractory disease, excluding participants intolerant to first-line treatments).

Disease progression (PD) as assessed after first-line treatment.

Disqualifiers

MRI of the brain shows evidence of central nervous system lymphoma; active primary central nervous system DLBL, unless central nervous system involvement has been effectively treated (i.e., participant is asymptomatic), and there has been more than a 4-week gap since local treatment.

Active central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with central nervous system involvement.

History of or concurrent diagnosis of malignancies other than CD19+ malignancies.

Clinically significant heart disease or arrhythmias that cannot be controlled with medication.

Trial design

Treatments tested in this trial

  • anti-CD20/CD30-CAR-T cells
  • Fludarabine
  • Cyclophosphamide

Treatment groups

9 Participants
are divided into 1 treatment group