B-cell LymphomaPhase 1NCT07369492
Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
A Phase 1 study testing BAFF-R CAR-T cells in people with B-cell Lymphoma, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative 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
- B-cell Lymphoma
- What is being tested?
- BAFF-R CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to Jan 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects voluntarily participate in clinical research and sign informed consent.
- 2. Subjects with CD19-negative relapsed or refractory B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).
- 3. Expected survival ≥ 3 months.
- 4. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.
- 5. ECOG score ≤ 2.
- 6. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:
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- Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m²
- Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.
- Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation >95% on room air.
- 7. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).
- 8. Adequate bone-marrow reserve without blood transfusion as defined by:
- Absolute neutrophil count (ANC) ≥ 1 x 10^9/L.
- Absolute lymphocyte count (ALC) ≥ 0.1 x 10^9/L.
- Platelets ≥ 50 x 10^9/L.
- Hemoglobin >80g/L.
- 9. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.
Who cannot join
- 1. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.
- 2. Infectious disease(HIV, Active Tuberculosis ect.).
- 3. Active infection: hepatitis B, hepatitis C.
- 4. Abnormal vital signs or refuse to receive examination.
- 5. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.
- 6. History of severe hypersensitivity or known hypersensitivity to IL-2.
- 7. Systemic or local severe infection requiring antimicrobial therapy.
- 8. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.
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, 1 recruiting
- Recruiting
Suzhou Hongci Hematology Hospital
Suzhou
Xiao Ma, 0512-83837999, colleenld2020@hotmail.com
About this study
Official title: A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.
Read the detailed description
This is a prospective open-label, single-arm clinical study to evaluate the safety, tolerability of BAFF-R CAR-T cells in adult subjects with CD19-negative relapsed or refractory B-Cell Lymphoma. The study plans to explore across three dose levels (1.00 × 10^6, 3.00 × 10^6, 9.00 × 10^6 CAR+ T cells/kg), and 6.00×10^8 CAR+T cells as maximum dose, aiming to evaluate the safety, tolerability of BAFF-R CAR-T cells in CD19-negative relapsed or refractory B-Cell Lymphoma, explore Maximum Tolerated Dose (MTD) and determine the recommended dose for Phase II. Besides, efficacy, pharmacokinetics and persistence profile of CAR-T cells are also study objectives.
- Conditions
- B-cell Lymphoma
- Being tested
- BAFF-R CAR-T cells
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAFF-R CAR-T cellsBiological
BAFF-R CAR-T cells, single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| BAFF-R CAR-T Cells treatment arm | Experimental | Subjects will be administrated with BAFF-R CAR-T Cells after lymphocyte depletion by fludarabine and cyclophosphamide. Receives: Biological: BAFF-R CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
Dose-limiting toxicity for each subject
Measured: 1 month after injection
AE/SAE
Incidence and severity of adverse events (AE), and serious adverse event (SAE)
Measured: 1 month, 3 months, 6 months, 12 months after injection
Secondary outcomes (4)
Objective response rate (ORR)
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Measured: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Overall survival (OS)
Defined as the time from the date of first infusion to death due to any cause
Measured: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Duration of response (DOR)
The time from the date of first response (PR or better) to the date of disease progression after infusion
Measured: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Progression-free survival (PFS)
The time from first infusion to the date of progression or death.
Measured: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369492
- Sponsor's protocol ID
- TH-RD09-01
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07369492
- Acronym / sponsor ID
- TH-RD09-01
- Conditions
- B-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 27 Jan 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 purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.
Detailed description
This is a prospective open-label, single-arm clinical study to evaluate the safety, tolerability of BAFF-R CAR-T cells in adult subjects with CD19-negative relapsed or refractory B-Cell Lymphoma. The study plans to explore across three dose levels (1.00 × 10^6, 3.00 × 10^6, 9.00 × 10^6 CAR+ T cells/kg), and 6.00×10^8 CAR+T cells as maximum dose, aiming to evaluate the safety, tolerability of BAFF-R CAR-T cells in CD19-negative relapsed or refractory B-Cell Lymphoma, explore Maximum Tolerated Dose (MTD) and determine the recommended dose for Phase II. Besides, efficacy, pharmacokinetics and persistence profile of CAR-T cells are also study objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAFF-R CAR-T Cells treatment arm | Experimental | Biological: BAFF-R CAR-T cellsSubjects will be administrated with BAFF-R CAR-T Cells after lymphocyte depletion by fludarabine and cyclophosphamide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Subjects voluntarily participate in clinical research and sign informed consent.
- 2. Subjects with CD19-negative relapsed or refractory B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).
- 3. Expected survival ≥ 3 months.
- 4. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.
- 5. ECOG score ≤ 2.
Key exclusion criteria (8 listed)
- 1. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.
- 2. Infectious disease(HIV, Active Tuberculosis ect.).
- 3. Active infection: hepatitis B, hepatitis C.
- 4. Abnormal vital signs or refuse to receive examination.
- 5. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.
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 |
|---|---|---|
| BAFF-R CAR-T cellsBAFF-R CAR-T cells, single intravenous infusion | Biological | BAFF-R CAR-T Cells treatment arm |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: 1 month after injection
Dose-limiting toxicity for each subject
AE/SAE
Time frame: 1 month, 3 months, 6 months, 12 months after injection
Incidence and severity of adverse events (AE), and serious adverse event (SAE)
4 secondary outcomes
Objective response rate (ORR)
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Overall survival (OS)
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Duration of response (DOR)
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after injection
Progression-free survival (PFS)
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months after injection
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAFF-R CAR-T cells in people with B-cell Lymphoma, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. 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 16 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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?
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?
Contact Xiao Ma (0512-83837999, colleenld2020@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (time frame: 1 month after injection). 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 27 Feb 2026.