About this trial
This is an open-lable, single arm, non-randomized study to evaluate the primary safety and efficacy of the novel bispecific AbTCR (anti-CD19/CD22)-T cells in patients with relapsed or refractory B-cell lymphoma
Eligibility criteria
Qualifiers
Age≥ 18 years;
Pathologically diagnosed CD19+/CD22+ B-cell lymphoma;
Relapsed or refractory after at least two prior lines of therapy;
Cardiac function: Left ventricular ejection fraction ≥50%;
Disqualifiers
Lymphoma involving only the central nervous system (CNS), or secondary CNS lymphoma patients judged by the investigator to be at high risk for AbTCR (anti-CD19/CD22)-T cell therapy;
History of other malignancies not in complete remission for at least 2 years (the following conditions are exempt from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumors with low risk of recurrence, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or PAP smear showing squamous intraepithelial lesion);
Positive hepatitis B surface antigen (HBsAg) (regardless of hepatitis B virus DNA copy number);
Positive hepatitis B core antibody (HBcAb) with increased hepatitis B virus DNA copy number;
Trial design
Treatments tested in this trial
- Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion
Treatment groups
Sponsors and collaborators
First Affiliated Hospital Xi'an Jiaotong University
Lead sponsor
Eureka Therapeutics Inc.
Collaborator