Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Relapsed or Refractory B-cell Lymphoma

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

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

3 Participants
are divided into 1 treatment group

Sponsors and collaborators