Relapsed or Refractory Non-Hodgkin's LymphomaPhase 1/2NCT05768529
Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase 1/2 study testing U16 in people with Relapsed or Refractory Non-Hodgkin's Lymphoma, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 3 sites in China.
Trial summary
The study is a Phase I/II, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed or Refractory Non-Hodgkin's Lymphoma
- What is being tested?
- U16
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 28 Mar 2023to 31 Dec 2030
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trial participants voluntarily sign the informed consent form and have good compliance;
- Age ≥18 years and ≤70 years at the time of signing the informed consent form; male or female trial participants are eligible;
- Indication: B-cell non-Hodgkin lymphoma that is CD20-positive as demonstrated by immunohistochemistry (IHC) staining of prior tumor tissue samples or by bone marrow cells, and consistent with the 2017 WHO classification of NHL, including: diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL) to large B-cell lymphoma, and high-grade B-cell lymphoma (HGBCL);
- Prior treatment with ≥2 lines of adequate therapy or autologous hematopoietic stem cell transplantation (ASCT). Adequate therapy includes: a) Must have received adequate treatment including anthracyclines and rituximab or other CD20-targeted agents (except for CD20-negative tumors); b) Lines of therapy: best response to first-line treatment was progressive disease (PD), or best response to at least 4 cycles of first-line treatment was stable disease (SD), or best response to at least 6 cycles of first-line treatment was PR; PD again during/after the last line of treatment (second-line or beyond), or best response to at least 2 cycles of the last line of treatment was SD. c) For TFL to large B-cell lymphoma: prior to transformation, the participant must have received adequate treatment for FL, and has relapsed or is refractory during/after the last line of treatment after transformation; if the initial diagnosis is transformed lymphoma, the participant must have received ≥2 lines of therapy and has relapsed or is refractory during/after the last line of treatment;
- In a state of disease relapse or refractoriness at screening: a) Definition of relapse: PD again after achieving response (including partial response (PR) or complete response (CR)) following adequate treatment; b) Definition of refractoriness: i. No response to the last treatment: PD during/after the last treatment or best response of SD with a duration of less than 6 months; ii. Relapse or progression after ASCT (confirmed by biopsy), including: relapse or PD within 12 months after ASCT; if salvage therapy was subsequently received, no response to the last treatment (SD or PD);
- According to the Lugano classification for lymphoma response assessment (Cheson 2014), at least 1 CT-measurable lesion (for nodal lesions: defined as long axis >1.5 cm; for extranodal lesions: long axis should be >1.0 cm), and a lesion confirmed positive by PET-CT;
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Adequate bone marrow reserve at screening, defined as: absolute neutrophil count (ANC) ≥ 1.0×10⁹/L, absolute lymphocyte count (ALC) ≥ 0.3×10⁹/L, platelet count (PLT) ≥ 50×10⁹/L;
- Adequate organ function, meeting the following criteria: aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3× ULN (for hepatic function abnormalities due to tumor infiltration, AST and ALT ≤5× ULN are required); total serum bilirubin ≤2× ULN, unless accompanied by Gilbert syndrome; trial participants with Gilbert syndrome who have total bilirubin ≤3× ULN and direct bilirubin ≤1.5× ULN may be enrolled. Serum creatinine ≤1.5× ULN, or creatinine clearance ≥60 mL/min (Cockcroft and Gault formula); minimum pulmonary reserve, defined as dyspnea ≤ grade 1 and oxygen saturation >91% without supplemental oxygen;
- Women of childbearing potential must have a negative blood/urine pregnancy test within 7 days before U16 cell infusion; any male or female trial participant of reproductive potential must agree to use effective contraceptive methods throughout the entire study and for at least one year after administration of the study treatment;
- Adequate venous access for apheresis or venous blood collection, and no other contraindications to leukapheresis;
- Washout period for CD20-targeted agents of at least 6 weeks before screening (applicable to trial participants who have received rituximab or other CD20-targeted agents);
- Expected survival greater than 3 months.
Who cannot join
- Concurrent other malignancies, except for malignancies with disease-free survival exceeding 3 years and carcinoma in situ;
- Trial participants with lymphoma infiltration of the cardiac atria or ventricles;
- Use of immunosuppressants, high-dose chemotherapy within 2 weeks before signing the informed consent form, or use of hormones within 3 days, or planned requirement for immunosuppressants or hormones after signing the informed consent form and before/after apheresis; specifically referring to systemic therapy, excluding local or inhaled corticosteroid therapy;
- History of immunodeficiency, including human immunodeficiency virus (HIV) infection; positive anti-Treponema pallidum antibody (TP-Ab); hepatitis B virus infection (hepatitis B surface antigen [HBsAg] positive and hepatitis B virus deoxyribonucleic acid [HBV-DNA] quantification > lower limit of detection); hepatitis C virus infection (hepatitis C virus [HCV] antibody positive and hepatitis C virus ribonucleic acid [HCV-RNA] quantification > lower limit of detection);
- Presence of bacterial, fungal, viral, mycoplasma, or other types of infection that the investigator judges to be difficult to control;
- Presence of active primary or secondary central nervous system (CNS) lymphoma at screening (trial participants with symptoms of CNS disease must undergo lumbar puncture to rule out CNS lymphoma);
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- Prior or current clinically significant CNS disease, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease;
- Coronary angioplasty or stent placement within 12 months before signing the informed consent form, or myocardial infarction, unstable angina pectoris, or other clinically significant cardiac history as judged by the investigator; severe arrhythmia requiring treatment; left ventricular ejection fraction (LVEF) ≤50%; hypertension inadequately controlled despite standard treatment (systolic ≥160 mmHg and/or diastolic ≥100 mmHg) or pulmonary arterial hypertension;
- Trial participants with clinical emergencies requiring urgent management due to lymphoma tumor mass obstruction or compression as judged by the investigator (such as intestinal obstruction or vascular compression, etc.);
- Trial participants who have previously received CD20-targeted CAR-T therapy;
- History of severe immediate hypersensitivity reaction to any drug to be used in this study;
- Receipt of live vaccine within 6 weeks before screening;
- Pregnant or breastfeeding women;
- Active autoimmune disease;
- Presence of active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form;
- Receipt of allogeneic hematopoietic stem cell transplantation within 6 months before signing the informed consent form;
- Any concomitant disease that may affect or interfere with the assessment of safety or efficacy;
- Presence of active deep vein thrombosis (tumor thrombus or thrombosis) or pulmonary embolism within 3 months before signing the ICF; however, if the investigator judges that the thrombosis has been clinically managed and there is no risk of dislodgement, enrollment is permitted;
- Any condition deemed by the investigator as unsuitable for participation in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Xin Li, P, +86-13808418932, 972978226@qq.com
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, PhD, +86-21-64370045, zwl_trial@163.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Depei Wu, PhD, +86-512-67781856, wudepei@suda.edu.cn
About this study
Official title: A Single-arm, Open and Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of U16 Injection in the Treatment of Refractory/Recurrent B-cell Non-Hodgkin's Lymphoma (r/r B-NHL)
The study is a Phase I/II, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively.
- Being tested
- U16
- Medical subject headings
- Recurrence, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U16Drug
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered before U16 treatment.
| Study group | Role | What they receive |
|---|---|---|
| U16 | Experimental | Route of administration: Intravenous injection.
Lymphodepletion conditioning:
Lymphodepletion will be conducted several days prior to U16 infusion.
A combination of fludarabine and cyclophosphamide will be used for lymphodepletion. Receives: Drug: U16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types, frequency and severity of adverse events
Safty of U16 as measured by types, frequency and severity of adverse events after U16 Injection infusion.
Measured: 24 months
Overall Remission Rate (ORR)
Efficacy of U16 as measured by ORR during the 3 months after U16 Injection infusion, which includes CR and PR.
Measured: 3 months
Secondary outcomes (9)
Complete Remission (CR)
Efficacy of U16 as measured by CR during the 3 months after U16 Injection infusion.
Measured: 3 months
Progression-free survival (PFS)
PFS means duration from the U16 Injection infusion to progression of lymphoma, or death for any reason.
Measured: 24 months
Duration of Remission (DOR)
DOR means the duration from reaching the response (e.g., CR or PR) criteria of the therapy to the first, clearly defined progressive disease, or death for disease under investigation.
Measured: 24 months
Overall Survival（OS）
OS means duration from the U16 Injection infusion to death for any reason, or the last follow-up for survival.
Measured: 24 months
Pharmacokinetic (PK)- Cmax
Maximum detected concentration of U16 in peripheral blood
Measured: 24 months
Pharmacokinetic (PK)- Tmax
Time to maximum concentration of U16 in peripheral blood
Measured: 24 months
Pharmacokinetic (PK)- AUC
Area under the concentration vs time curve of U16 in peripheral blood
Measured: 24 months
Concentration of Cytokines in Serum
Collected as pharmacodynamic data, including IL-6 at least
Measured: 24 months
Concentration of B cells
Measure B cells in peripheral blood
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start28 Mar 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Non-Hodgkin's 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768529
- Sponsor's protocol ID
- U16-I/II-01
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open and Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of U16 Injection in the Treatment of Refractory/Recurrent B-cell Non-Hodgkin's Lymphoma (r/r B-NHL)
- ClinicalTrials.gov ID
- NCT05768529
- Acronym / sponsor ID
- U16-I/II-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Mar 2023 (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 study is a Phase I/II, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U16 | Experimental | Drug: U16Route of administration: Intravenous injection. Lymphodepletion conditioning: Lymphodepletion will be conducted several days prior to U16 infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Trial participants voluntarily sign the informed consent form and have good compliance;
- Age ≥18 years and ≤70 years at the time of signing the informed consent form; male or female trial participants are eligible;
- Indication: B-cell non-Hodgkin lymphoma that is CD20-positive as demonstrated by immunohistochemistry (IHC) staining of prior tumor tissue samples or by bone marrow cells, and consistent with the 2017 WHO classification of NHL, including: diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL) to large B-cell lymphoma, and high-grade B-cell lymphoma (HGBCL);
- Prior treatment with ≥2 lines of adequate therapy or autologous hematopoietic stem cell transplantation (ASCT). Adequate therapy includes: a) Must have received adequate treatment including anthracyclines and rituximab or other CD20-targeted agents (except for CD20-negative tumors); b) Lines of therapy: best response to first-line treatment was progressive disease (PD), or best response to at least 4 cycles of first-line treatment was stable disease (SD), or best response to at least 6 cycles of first-line treatment was PR; PD again during/after the last line of treatment (second-line or beyond), or best response to at least 2 cycles of the last line of treatment was SD. c) For TFL to large B-cell lymphoma: prior to transformation, the participant must have received adequate treatment for FL, and has relapsed or is refractory during/after the last line of treatment after transformation; if the initial diagnosis is transformed lymphoma, the participant must have received ≥2 lines of therapy and has relapsed or is refractory during/after the last line of treatment;
- In a state of disease relapse or refractoriness at screening: a) Definition of relapse: PD again after achieving response (including partial response (PR) or complete response (CR)) following adequate treatment; b) Definition of refractoriness: i. No response to the last treatment: PD during/after the last treatment or best response of SD with a duration of less than 6 months; ii. Relapse or progression after ASCT (confirmed by biopsy), including: relapse or PD within 12 months after ASCT; if salvage therapy was subsequently received, no response to the last treatment (SD or PD);
Key exclusion criteria (19 listed)
- Concurrent other malignancies, except for malignancies with disease-free survival exceeding 3 years and carcinoma in situ;
- Trial participants with lymphoma infiltration of the cardiac atria or ventricles;
- Use of immunosuppressants, high-dose chemotherapy within 2 weeks before signing the informed consent form, or use of hormones within 3 days, or planned requirement for immunosuppressants or hormones after signing the informed consent form and before/after apheresis; specifically referring to systemic therapy, excluding local or inhaled corticosteroid therapy;
- History of immunodeficiency, including human immunodeficiency virus (HIV) infection; positive anti-Treponema pallidum antibody (TP-Ab); hepatitis B virus infection (hepatitis B surface antigen [HBsAg] positive and hepatitis B virus deoxyribonucleic acid [HBV-DNA] quantification > lower limit of detection); hepatitis C virus infection (hepatitis C virus [HCV] antibody positive and hepatitis C virus ribonucleic acid [HCV-RNA] quantification > lower limit of detection);
- Presence of bacterial, fungal, viral, mycoplasma, or other types of infection that the investigator judges to be difficult to control;
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 |
|---|---|---|
| U16A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered before U16 treatment. | Drug | U16 |
Primary outcome
Types, frequency and severity of adverse events
Time frame: 24 months
Safty of U16 as measured by types, frequency and severity of adverse events after U16 Injection infusion.
Overall Remission Rate (ORR)
Time frame: 3 months
Efficacy of U16 as measured by ORR during the 3 months after U16 Injection infusion, which includes CR and PR.
9 secondary outcomes
Complete Remission (CR)
Time frame: 3 months
Progression-free survival (PFS)
Time frame: 24 months
Duration of Remission (DOR)
Time frame: 24 months
Overall Survival（OS）
Time frame: 24 months
Pharmacokinetic (PK)- Cmax
Time frame: 24 months
Pharmacokinetic (PK)- Tmax
Time frame: 24 months
Pharmacokinetic (PK)- AUC
Time frame: 24 months
Concentration of Cytokines in Serum
Time frame: 24 months
Concentration of B cells
Time frame: 24 months
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 2 Oct 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing U16 in people with Relapsed or Refractory Non-Hodgkin's Lymphoma, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 3 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 13 inclusion and 19 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaoyan Lou, PhD (+86-18721281671, xiaoyan.lou@unicar-therapy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types, frequency and severity of adverse events (time frame: 24 months). 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 2 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.