LymphomaPhase 1NCT07383233
CD19/BAFF-R in Vivo CAR-T Cell Therapy Targeting Relapsed/Refractory B Cell Acute Leukemia/Malignant Lymphoma
A Phase 1 study testing CD19/BAFF-R in vivo CAR-T cell intravenous infusion in people with Lymphoma and CAR T Cell Therapy, run by Qi deng.
Trial summary
The currently CAR-T cell therapy in clinical practice largely depends on the expansion of CAR-T cells in vivo. However, the in vitro preparation process of CAR-T cells is complex and costly. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Lymphoma, CAR T Cell Therapy, Acute Leukemia
- What is being tested?
- CD19/BAFF-R in vivo CAR-T cell intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 May 2028
- Phase
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria：
- The diagnosis was confirmed as B-cell acute leukemia/malignant lymphoma. Requirements for prior treatment: Patients with B-cell acute leukemia/malignant lymphoma who failed to achieve PR after first-line therapy or experienced relapse within 12 months after first-line therapy; or those with relapsed/refractory disease after second-line therapy (a standardized chemotherapy regimen plus salvage chemotherapy). During screening, the patient was in a state of disease recurrence or refractory condition: Acute B-cell leukemia: a) Relapse definition: The presence of blast cells (proportion>5%) in peripheral blood or bone marrow after achieving complete remission with a standardized treatment regimen (including hematopoietic stem cell transplantation), or the development of extramedullary disease; b) Refractory definition: Failure to achieve complete remission after at least two courses of standardized induction therapy. B-cell lymphoma: a) Definition of relapse: PD after achieving remission (including partial response (PR) or complete response (CR)) following adequate treatment; b) Definition of refractory: i. No response to the last treatment: PD during/after the last treatment or SD with a duration of less than 6 months; ii. Relapse or progression after ASCT, including: relapse or PD within 12 months after ASCT, and no response to the last treatment (SD or PD) if salvage therapy is administered.
- The subject's predicted survival time is not less than three months.
- Tumor cells confirmed to be CD19/BAFFR positive by Flow Cytometry (FCM) or Immunohistochemistry.
- Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed/refractory B-cell lymphoma (B-LY) who have at least one evaluable lesion.
- Age 14-75 years (inclusive), both genders eligible.
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- ECOG performance status ≤ 3.
- HGB≥70g/L(transfusion permitted).
- The functions of vital organs need to meet the following conditions: ①Creatinine ≤ 2.5 × ULN or Cockcroft-Gault creatinine clearance > 50 ml/min (excluding decreased serum creatinine clearance due to lymphoma mass compression), Combination with hemodialysis treatment is permitted. ②LVEF≥50%,② Oxygen saturation ≥90%,③ SCr≤2.5ULN,④ALT and AST≤3ULN,TBil≤2ULN. In the investigator's judgment, if organ dysfunction is associated with the current disease, the enrollment decision will be made by the investigator.
- Subjects intending to conceive must agree to use contraception prior to study enrollment and for six months post-study. In the event of pregnancy or suspected pregnancy, they should promptly notify the investigator.
- The subject or guardian understands and signs the Informed Consent Form (ICF).
Who cannot join
- Any of the following conditions will not be eligible for enrolment:
- Severe heart failure with left ventricular ejection fraction (LVEF) < 50%.
- History of severe pulmonary function impairment.
- Concurrent other progressive malignant tumors.
- Concurrent severe infection that cannot be effectively controlled.
- Concurrent severe autoimmune disease or congenital immunodeficiency.
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- Active hepatitis (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive with HBV DNA copy number greater than the upper limit of normal at the study center; Anti-HCV positive with HCV-RNA copy number greater than the upper limit of normal at the study center).
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
- History of severe allergy to biological products (including antibiotics).
- Received inactivated vaccines such as influenza vaccine, COVID-19 vaccine within 4 weeks prior to screening, or received live attenuated vaccines (such as measles, varicella vaccines) within 8 weeks.
- Patients with other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, and patients considered unsuitable for this study by the investigator.
About this study
Official title: Clinical Study on the Efficacy and Safety of CD19/BAFF-R in Vivo CAR-T Cell Therapy Targeting Relapsed/Refractory B Cell Acute Leukemia/Malignant Lymphoma
The currently CAR-T cell therapy in clinical practice largely depends on the expansion of CAR-T cells in vivo. However, the in vitro preparation process of CAR-T cells is complex and costly. In vivo CAR-T cell therapy eliminates the need for ex vivo preparation, significantly reducing treatment costs and procedural complexity. It enables immediate use, thereby improving patient accessibility. CD19 is stably overexpressed in more than 90% of B-cell malignancies. BAFF plays a core regulatory role in the survival, maturation, and homeostasis maintenance of B cells. BAFF-R is selectively expressed on the surface of mature B cell subsets and most B-cell malignancies. Currently, BAFF-R-based CAR-T therapy is in preclinical and early clinical research stages, demonstrating promising therapeutic potential, particularly offering a novel treatment option for patients with CD19-negative or drug-resistant B-cell tumors. The use of CD19/BAFF-R in vivo CAR-T cells as a new anti-tumor therapy may provide a new research direction for the treatment of relapsed/refractory B-cell acute leukemia/malignant lymphoma.
- Conditions
- Lymphoma, CAR T Cell Therapy, Acute Leukemia
- Being tested
- CD19/BAFF-R in vivo CAR-T cell intravenous infusion
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/BAFF-R in vivo CAR-T cell intravenous infusionBiological
CD19/BAFF-R in vivo CAR-T cell intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CD19/BAFF-R in vivo CAR-T cell therapy | Experimental | Not described Receives: Biological: CD19/BAFF-R in vivo CAR-T cell intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of CD19/BAFF-R in vivo CAR-T cell therapy in relapsed/refractory B Cell Acute Leukemia/Malignant Lymphoma
the incidence and severity of immune therapy related toxic reactions (irAEs)
Measured: up to one month after the CAR-T infusion
Evaluate the effcacy of CD19/BAFF-R in vivo CAR-T cell therapy in relapsed/refractory B Cell Acute Leukemia/Malignant Lymphoma
CR rate on M1 and M3
Measured: one month and three month after the CAR-T infusion
Secondary outcomes (2)
Cell pharmacokinetics Dynamic indicators
CAR-T/T% by flow cytometry
Measured: Day7, Day10, Day14, Day28 after the CAR-T infusion
long-term efficacy
OS
Measured: up to one year after the CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qi deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi deng, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383233
- Sponsor's protocol ID
- XBAP2025-10
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 3 Feb 2026
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of CD19/BAFF-R in Vivo CAR-T Cell Therapy Targeting Relapsed/Refractory B Cell Acute Leukemia/Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT07383233
- Acronym / sponsor ID
- XBAP2025-10
- Conditions
- Lymphoma, CAR T Cell Therapy, Acute Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Qi dengUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 Feb 2026 (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.
The currently CAR-T cell therapy in clinical practice largely depends on the expansion of CAR-T cells in vivo. However, the in vitro preparation process of CAR-T cells is complex and costly. In vivo CAR-T cell therapy eliminates the need for ex vivo preparation, significantly reducing treatment costs and procedural complexity. It enables immediate use, thereby improving patient accessibility. CD19 is stably overexpressed in more than 90% of B-cell malignancies. BAFF plays a core regulatory role in the survival, maturation, and homeostasis maintenance of B cells. BAFF-R is selectively expressed on the surface of mature B cell subsets and most B-cell malignancies. Currently, BAFF-R-based CAR-T therapy is in preclinical and early clinical research stages, demonstrating promising therapeutic potential, particularly offering a novel treatment option for patients with CD19-negative or drug-resistant B-cell tumors. The use of CD19/BAFF-R in vivo CAR-T cells as a new anti-tumor therapy may provide a new research direction for the treatment of relapsed/refractory B-cell acute leukemia/malignant lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19/BAFF-R in vivo CAR-T cell therapy | Experimental | Biological: CD19/BAFF-R in vivo CAR-T cell intravenous infusion |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following criteria：
- The diagnosis was confirmed as B-cell acute leukemia/malignant lymphoma. Requirements for prior treatment: Patients with B-cell acute leukemia/malignant lymphoma who failed to achieve PR after first-line therapy or experienced relapse within 12 months after first-line therapy; or those with relapsed/refractory disease after second-line therapy (a standardized chemotherapy regimen plus salvage chemotherapy). During screening, the patient was in a state of disease recurrence or refractory condition: Acute B-cell leukemia: a) Relapse definition: The presence of blast cells (proportion>5%) in peripheral blood or bone marrow after achieving complete remission with a standardized treatment regimen (including hematopoietic stem cell transplantation), or the development of extramedullary disease; b) Refractory definition: Failure to achieve complete remission after at least two courses of standardized induction therapy. B-cell lymphoma: a) Definition of relapse: PD after achieving remission (including partial response (PR) or complete response (CR)) following adequate treatment; b) Definition of refractory: i. No response to the last treatment: PD during/after the last treatment or SD with a duration of less than 6 months; ii. Relapse or progression after ASCT, including: relapse or PD within 12 months after ASCT, and no response to the last treatment (SD or PD) if salvage therapy is administered.
- The subject's predicted survival time is not less than three months.
- Tumor cells confirmed to be CD19/BAFFR positive by Flow Cytometry (FCM) or Immunohistochemistry.
- Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed/refractory B-cell lymphoma (B-LY) who have at least one evaluable lesion.
Key exclusion criteria (11 listed)
- Severe heart failure with left ventricular ejection fraction (LVEF) < 50%.
- History of severe pulmonary function impairment.
- Concurrent other progressive malignant tumors.
- Concurrent severe infection that cannot be effectively controlled.
- Concurrent severe autoimmune disease or congenital immunodeficiency.
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 |
|---|---|---|
| CD19/BAFF-R in vivo CAR-T cell intravenous infusionCD19/BAFF-R in vivo CAR-T cell intravenous infusion | Biological | CD19/BAFF-R in vivo CAR-T cell therapy |
Primary outcome
Evaluate the safety of CD19/BAFF-R in vivo CAR-T cell therapy in relapsed/refractory B Cell Acute Leukemia/Malignant Lymphoma
Time frame: up to one month after the CAR-T infusion
the incidence and severity of immune therapy related toxic reactions (irAEs)
Evaluate the effcacy of CD19/BAFF-R in vivo CAR-T cell therapy in relapsed/refractory B Cell Acute Leukemia/Malignant Lymphoma
Time frame: one month and three month after the CAR-T infusion
CR rate on M1 and M3
2 secondary outcomes
Cell pharmacokinetics Dynamic indicators
Time frame: Day7, Day10, Day14, Day28 after the CAR-T infusion
long-term efficacy
Time frame: up to one year after the CAR-T infusion
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 3 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19/BAFF-R in vivo CAR-T cell intravenous infusion in people with Lymphoma and CAR T Cell Therapy, run by Qi deng.
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 11 inclusion and 11 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of CD19/BAFF-R in vivo CAR-T cell therapy in relapsed/refractory B Cell Acute Leukemia/Malignant Lymphoma (time frame: up to one month after the CAR-T infusion). The study lists 2 primary outcomes in all. 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 3 Feb 2026.