Diffuse Large B Cell Lymphoma (DLBCL)Early Phase 1NCT07168291
Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Relapsed or Refractory B-cell Lymphoma
A Early Phase 1 study testing Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion in people with Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma ( FL), run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL), Follicular Lymphoma ( FL), Burkitt Lymphoma
- What is being tested?
- Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Cladribine within 3 months prior to leukapheresis;
- Fludarabine within 3 months prior to leukapheresis;
- Anti-CD20 monoclonal antibody within 7 days prior to leukapheresis;
- Venetoclax within 4 days prior to leukapheresis;
- Idelalisib within 2 days prior to leukapheresis;
- Lenalidomide within 1 day prior to leukapheresis;
- Therapeutic doses of corticosteroids (defined as prednisone or equivalent >20 mg/day) within 7 days prior to leukapheresis; physiological replacement, topical, and inhaled steroids are permitted;
- Non-lymphocytotoxic chemotherapy within 1 week prior to leukapheresis. Oral chemotherapy drugs are allowed if at least 3 half-lives have passed prior to leukapheresis;
- Lymphocytotoxic chemotherapy (e.g., cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan) within 2 weeks prior to leukapheresis;
- Investigational drugs within 4 weeks prior to leukapheresis. However, subjects who had no response or disease progression during experimental treatment and for whom at least 3 half-lives have passed since the last dose prior to leukapheresis are allowed;
- GvHD therapy (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL6, or anti-IL6R) within 4 weeks prior to leukapheresis and AbTCR (anti-CD19/CD22)-T cell infusion;
- Donor lymphocyte infusion (DLI) within 6 weeks prior to AbTCR (anti-CD19/CD22)-T cell administration;
- Radiotherapy within 6 weeks prior to leukapheresis, including large bone marrow areas such as the sternum or pelvis. Patients with progressive disease at irradiated sites or PET-positive lesions at non-irradiated sites are eligible. Radiotherapy to a single site is allowed within 2 weeks prior to leukapheresis if there are PET-positive lesions at other non-irradiated sites;
- If prior immunotherapy such as anti-PD1 or anti-PD-L1 was used, at least 5 half-lives must have passed between the last dose and AbTCR (anti-CD19/CD22)-T cell infusion;
- Prior allogeneic hematopoietic stem cell transplantation;
- Other conditions considered inappropriate by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: The Safety and Efficacy of Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Patients With Relapsed or Refractory B-cell Lymphoma: An Open-label, Single-arm Clinical Study
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
Read the detailed description
The investigators previously developed CD19-targeted ET019003 T cells by fusing the Fab fragment with γ/δ TCR constant chain plus adding a co-stimulatory molecule. Among 12 treated patients enrolled in the phase I clinical trial (NCT03642496), 6 achieved complete remission and no serious adverse events were observed, demonstrating that ET019003 T cells are both safe and effective. However, its efficacy is limited in patients with loss of CD19 expression. To overcome tumor immune escape driven by antigen loss, investigators designed the novel AbTCR-T cells simultaneously targeting CD19 and CD22. This trial is conducted to explore the safety and efficacy of AbTCR (anti-CD19/CD22)-T cells in treating patients with refractory/relapsed aggressive lymphomas.
- Being tested
- Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion
- Keywords
- AbTCR-T, CD19/CD22, B-cell lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Burkitt Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Conditioning chemotherapy plus AbTCR (anti-CD19/CD22)-T cells | Experimental | The trial will enroll 3 patients with relapsed or refractory B-cell lymphoma. Receives: Drug: Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
Overall response rate (ORR) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B cell lymphoma.
ORR will be assessed from AbTCR (anti-CD19/CD22)-T cell infusion to death or last follow-up (censored).
Measured: 3 years
Overall survival (OS) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.
OS will be assessed from AbTCR (anti-CD19/CD22)-T cell infusion to death or last follow-up (censored).
Measured: 3 years
Progress-free survival (PFS) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.
PFS will be assessed from AbTCR (anti-CD19/CD22)-T cell infusion to death or last follow-up (censored).
Measured: 3 years
Duration of Response (DOR) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.
DOR will be assessed from AbTCR (anti-CD19/CD22)-T cell infusion to death or last follow-up (censored).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eureka Therapeutics Inc.
- Responsible party
- Principal investigator, He Pengcheng, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Pengcheng He, M.D., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168291
- Sponsor's protocol ID
- XJTU1AF2025LSYY-461
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Patients With Relapsed or Refractory B-cell Lymphoma: An Open-label, Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT07168291
- Acronym / sponsor ID
- XJTU1AF2025LSYY-461
- Keywords
- AbTCR-T, CD19/CD22, B-cell lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Eureka Therapeutics Inc.
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The investigators previously developed CD19-targeted ET019003 T cells by fusing the Fab fragment with γ/δ TCR constant chain plus adding a co-stimulatory molecule. Among 12 treated patients enrolled in the phase I clinical trial (NCT03642496), 6 achieved complete remission and no serious adverse events were observed, demonstrating that ET019003 T cells are both safe and effective. However, its efficacy is limited in patients with loss of CD19 expression. To overcome tumor immune escape driven by antigen loss, investigators designed the novel AbTCR-T cells simultaneously targeting CD19 and CD22. This trial is conducted to explore the safety and efficacy of AbTCR (anti-CD19/CD22)-T cells in treating patients with refractory/relapsed aggressive lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conditioning chemotherapy plus AbTCR (anti-CD19/CD22)-T cells | Experimental | Drug: Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusionThe trial will enroll 3 patients with relapsed or refractory B-cell lymphoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Adequate vascular access for leukapheresis;
Key exclusion criteria (31 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusionCyclophosphamide 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. | Drug | Conditioning chemotherapy plus AbTCR (anti-CD19/CD22)-T cells |
Primary outcome
Incidence of Treatment-related Adverse Events
Time frame: 3 years
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.
4 secondary outcomes
Overall response rate (ORR) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B cell lymphoma.
Time frame: 3 years
Overall survival (OS) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.
Time frame: 3 years
Progress-free survival (PFS) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.
Time frame: 3 years
Duration of Response (DOR) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pengcheng He, M.D. principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion in people with Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma ( FL), run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengcheng He, M.D. (+86-029-85324035, hepc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-related Adverse Events (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.