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

NCT07168291 | Not Yet Recruiting Early Phase 1

• 1 other identifier: XJTU1AF2025LSYY-461
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B Cell Lymphoma (DLBCL); Follicular Lymphoma ( FL); Burkitt Lymphoma

Keywords

AbTCR-T; CD19/CD22; B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-related Adverse Events

  Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) or ASTCT consensus.

  3 years

Secondary Outcomes (4)

• Overall response rate (ORR) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B cell lymphoma.

  3 years

• Overall survival (OS) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.

  3 years

• Progress-free survival (PFS) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.

  3 years

• Duration of Response (DOR) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.

  3 years

Other Outcomes (1)

• Expansion, persistence, and infiltration of AbTCR (anti-CD19/CD22)-T cells in peripheral blood, bone marrow, and tumor tissues.

  3 years

Study Arms (1)

Conditioning chemotherapy plus AbTCR (anti-CD19/CD22)-T cells

EXPERIMENTAL

The trial will enroll 3 patients with relapsed or refractory B-cell lymphoma.

Drug: Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion

Interventions

Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion DRUG

Cyclophosphamide 250 mg/m2 and fludarabine 30 mg/m2 IV infusion on day -5, -4, and -3. AbTCR (anti-CD19/CD22)-T cell IV infusion on day 0.

Conditioning chemotherapy plus AbTCR (anti-CD19/CD22)-T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 18 years;
• Pathologically diagnosed CD19+/CD22+ B-cell lymphoma;
• Relapsed or refractory after at least two prior lines of therapy;
• Patient's main organs functioning well:
• Cardiac function: Left ventricular ejection fraction ≥50%;
• Liver function: ALT and AST ≤2.5 × upper limit of normal (ULN), total bilirubin ≤2 × ULN;
• Renal function: Serum creatinine ≤3.0 mg/dL (≤260 μmol/L);
• Pulmonary function: ≤CTCAE grade 1 dyspnea and Indoor oxygen saturation ≥92%;
• Adequate bone marrow function as assessed by the investigator to receive lymphodepleting chemotherapy;
• Adequate vascular access for leukapheresis;
• Women of childbearing potential (all women physiologically capable of becoming pregnant) must agree to use highly effective contraception for 1 year after AbTCR (anti-CD19/CD22)-T cell infusion, such as copper-containing intrauterine device, hormonal implants, or tubal ligation; male subjects with partners of childbearing potential must agree to use effective barrier contraception for 1 year after AbTCR (anti-CD19/CD22)-T cell infusion;
• Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.

You may not qualify if:

• 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);
• Any of the following at screening:
• 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;
• Hepatitis C, human immunodeficiency virus (HIV), or syphilis infection;
• Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 3 months prior to signing informed consent;
• Ongoing anticoagulant therapy for deep vein thrombosis (DVT) or pulmonary embolism (PE) within 3 months prior to signing informed consent;
• Uncontrolled systemic fungal, bacterial, viral, or other infection;
• Acute or chronic graft-versus-host disease (GvHD);
• History of any of the following cardiovascular diseases within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart disease;
• History of or current clinically significant CNS disease at screening, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness;
• Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to starting lymphodepleting chemotherapy;
• Use of any of the following drugs or treatments within the specified timeframes prior to leukapheresis:
• Alemtuzumab within 6 months prior to leukapheresis;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Eureka Therapeutics Inc.: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Burkitt Lymphoma; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Pengcheng He, M.D.

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengcheng He, M.D.

CONTACT

+86-029-85324035; hepc@163.com

Busheng Xue, M.D.

CONTACT

18209228012; bushengxue@xjtufh.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

CN (1)