B-cell LymphomaPhase 1NCT07093086
Clinical Study of Multi-targeted CAR-T Therapy in Patients With Relapsed/Refractory B-Cell Lymphoma
A Phase 1 study testing Triple-targeted CAR-T Therapy in people with B-cell Lymphoma, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 2 sites in China.
Trial summary
This is a single-arm, open-label clinical study evaluating the efficacy and safety of CD20/CD19/CD22 multi-targeted chimeric antigen receptor T-cell (CAR-T) injection in patients with relapsed/refractory B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- B-cell Lymphoma
- What is being tested?
- Triple-targeted CAR-T Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesChina
- Study dates
- 7 Nov 2024to 30 Jan 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Voluntary written informed consent obtained from the participant (or legally authorized representative) with good compliance expected throughout the study.
- All of the following must be fulfilled:
- Age 2-75 years at the time of informed consent; both sexes eligible.For minors (≤18 years), consent must be provided by a parent or legal guardian; minors who are able to sign must co-sign with their guardian.
- Histologically confirmed B-cell lymphoma according to the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (2024 v3).
- Relapsed or refractory B-cell lymphoma after at least two prior lines of therapy (one standard chemo-regimen + one salvage regimen) that must have included:
- anti-CD20 monoclonal antibody (except for subjects with documented CD20-negative tumors), and
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- an anthracycline-containing regimen.
- Subjects must additionally meet at least one of the following:
- Ineligible for autologous hematopoietic stem-cell transplantation (ASCT); ii. Refusal of ASCT; iii. Relapse after ASCT. d) Disease status at screening:
- Relapse: progression after prior response (PR or CR).
- Refractory: i. No response to last therapy (progressive disease [PD] during/after, or best response ≤SD lasting <6 months); OR ii. Relapse or progression after ASCT (biopsy-proven) including: relapse/PD ≤12 months post-ASCT, or relapse/PD after salvage therapy post-ASCT without response (SD or PD).
- Tumor tissue (archival or fresh biopsy) positive for CD20 and/or CD19 and/or CD22 by immunohistochemistry (pathology report within 6 months preferred).
- ≥1 measurable lesion per Lugano 2014 (Cheson) criteria.
- ECOG performance status 0-3.
- Adequate marrow reserve at screening:Absolute lymphocyte count (ALC) ≥0.3 × 10⁹/L; Platelets ≥30 × 10⁹/L (transfusion permitted).
- Adequate organ function:AST ≤3×ULN (≤5×ULN if attributable to tumor infiltration); ALT ≤3×ULN (≤5×ULN if attributable to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN with direct bilirubin ≤1.5×ULN for Gilbert's syndrome); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault); Pulmonary reserve: ≤Grade 1 dyspnea and SpO₂ >91 % on room air; LVEF ≥50 % by echocardiography; INR ≤1.5×ULN and APTT ≤1.5×ULN.
- Women of child-bearing potential must have a negative serum/urine pregnancy test within 7 days before CAR-T infusion. All participants with reproductive potential must use effective contraception from screening through at least 12 months after the last CAR-T dose.
- Adequate venous access for leukapheresis or repeated phlebotomy, with no contraindications to leukapheresis.
- Anticipated survival ≥3 months.
Who cannot join
- Concurrent malignancy other than the study indication. Exceptions: carcinoma in situ or any malignancy with disease-free survival ≥3 years.
- Use of immunosuppressive agents or systemic corticosteroids within 1 week before leukapheresis that, in the investigator's judgment, could substantially impair T-cell function.
- Presence of any of the following:• Positive HBe-Ab and/or HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody.
- Active bacterial, fungal, viral, mycoplasmal, or other infection that, in the investigator's opinion, cannot be adequately controlled.
- Prior or current CNS disorders unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-deemed uncontrolled by the investigator.
- Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), or NYHA Class III-IV congestive heart failure, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease judged by the investigator. QTc interval >480 ms (Fridericia correction), or left-ventricular ejection fraction <50 % by echocardiography at screening.
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- Known primary immunodeficiency.
- History of severe immediate hypersensitivity to any study-related drug.
- Receipt of any live vaccine within 6 weeks before screening.
- Pregnant or breastfeeding women.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Participation in any other interventional clinical trial within 30 days before signing informed consent.
- Any condition that, in the investigator's opinion, renders the subject unsuitable for study participation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hebei Yanda Ludaopei Hospital
Hebei
Tongji Hospital of Tongji University
Shanghai
About this study
Official title: A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of CD20/CD19/CD22 Multi-targeted Chimeric Antigen Receptor T-cell (CAR-T) Injection in Patients With Relapsed/Refractory B-cell Lymphoma.
This is a single-arm, open-label clinical study evaluating the efficacy and safety of CD20/CD19/CD22 multi-targeted chimeric antigen receptor T-cell (CAR-T) injection in patients with relapsed/refractory B-cell lymphoma.
Read the detailed description
The primary objective of this study is to assess the safety and efficacy of CD19/CD20/CD22 muti-target CAR-T therapy in patients with relapsed or refractory B-cell lymphoma.
- Conditions
- B-cell Lymphoma
- Being tested
- Triple-targeted CAR-T Therapy
- Keywords
- CAR-T, CD19, CD22, CD20
- 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.
Triple-targeted CAR-T TherapyDrug
Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Multi-targeted CAR-T Therapy | Experimental | Patients will receive a regimen combining CD19/CD22 dual-targeted CAR-T cells with CD19/CD20 dual-targeted CAR-T cells; investigators may administer them sequentially according to each patient's condition. Receives: Drug: Triple-targeted CAR-T Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: 28 days post administration of CAR-T-cells
Objective Response Rate (ORR), as assessed by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or Partial Remission (PR)
Measured: 2 years post CAR T cell infusion
Duration of response (DOR), as assessed by Investigators
Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.
Measured: 2 years post CAR T cell infusion
Progression-free survival (PFS), as assessed by Investigators
Progression-free survival (PFS) was defined as the time from the date of infusion to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Measured: 2 years post CAR T cell infusion
Overall survival (OS)
Overall Survival (OS) was defined as the time from the date of first infusion to the date of death due to any cause.
Measured: 2 years post CAR T cell infusion
Secondary outcomes (4)
Pharmacokinetics of CAR-T cells
Time at the maximal concentration(Tmax)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of CAR-T cells
Area under the concentration-time curve(AUC)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of CAR-T cells
The maximal concentration of peripheral blood (Cmax)
Measured: 2 years post CAR T cell infusion
Pharmacodynamics of CAR-T cells
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
Measured: 2 years post CAR T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start7 Nov 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Why it stopped: The primary consideration is the allocation of company resources, and we have no choice but to terminate this research.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junfang Yang, Ph.D., Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093086
- Sponsor's protocol ID
- U05
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 6 May 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of CD20/CD19/CD22 Multi-targeted Chimeric Antigen Receptor T-cell (CAR-T) Injection in Patients With Relapsed/Refractory B-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT07093086
- Acronym / sponsor ID
- U05
- Conditions
- B-cell Lymphoma
- Keywords
- CAR-T, CD19, CD22, CD20
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The primary consideration is the allocation of company resources, and we have no choice but to terminate this research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 30 Jul 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 a single-arm, open-label clinical study evaluating the efficacy and safety of CD20/CD19/CD22 multi-targeted chimeric antigen receptor T-cell (CAR-T) injection in patients with relapsed/refractory B-cell lymphoma.
Detailed description
The primary objective of this study is to assess the safety and efficacy of CD19/CD20/CD22 muti-target CAR-T therapy in patients with relapsed or refractory B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-targeted CAR-T Therapy | Experimental | Drug: Triple-targeted CAR-T TherapyPatients will receive a regimen combining CD19/CD22 dual-targeted CAR-T cells with CD19/CD20 dual-targeted CAR-T cells; investigators may administer them sequentially according to each patient's condition. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Voluntary written informed consent obtained from the participant (or legally authorized representative) with good compliance expected throughout the study.
- All of the following must be fulfilled:
- Tumor tissue (archival or fresh biopsy) positive for CD20 and/or CD19 and/or CD22 by immunohistochemistry (pathology report within 6 months preferred).
- ≥1 measurable lesion per Lugano 2014 (Cheson) criteria.
- ECOG performance status 0-3.
Key exclusion criteria (13 listed)
- Concurrent malignancy other than the study indication. Exceptions: carcinoma in situ or any malignancy with disease-free survival ≥3 years.
- Use of immunosuppressive agents or systemic corticosteroids within 1 week before leukapheresis that, in the investigator's judgment, could substantially impair T-cell function.
- Presence of any of the following:• Positive HBe-Ab and/or HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody.
- Active bacterial, fungal, viral, mycoplasmal, or other infection that, in the investigator's opinion, cannot be adequately controlled.
- Prior or current CNS disorders unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-deemed uncontrolled by the investigator.
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 |
|---|---|---|
| Triple-targeted CAR-T TherapyLymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days. | Drug | Multi-targeted CAR-T Therapy |
Primary outcome
Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability]
Time frame: 28 days post administration of CAR-T-cells
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Objective Response Rate (ORR), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or Partial Remission (PR)
Duration of response (DOR), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.
Progression-free survival (PFS), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
Progression-free survival (PFS) was defined as the time from the date of infusion to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Overall survival (OS)
Time frame: 2 years post CAR T cell infusion
Overall Survival (OS) was defined as the time from the date of first infusion to the date of death due to any cause.
4 secondary outcomes
Pharmacokinetics of CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacodynamics of CAR-T cells
Time frame: 2 years post CAR T cell infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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. This study is not recruiting at the moment.
Junfang Yang, Ph.D. principal investigator
Hebei Yanda Ludaopei Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Triple-targeted CAR-T Therapy in people with B-cell Lymphoma, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 2 sites 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 19 inclusion and 13 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: withdrawn, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days post administration of CAR-T-cells). The study lists 5 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 6 May 2026.