CD19-positive Relapsed or Refractory B-cell MalignanciesEarly Phase 1NCT06092047
UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.
A Early Phase 1 study testing UTAA09 cells for infusion, Fludarabine and Cyclophosphamide in people with CD19-positive Relapsed or Refractory B-cell Malignancies, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- CD19-positive Relapsed or Refractory B-cell Malignancies
- What is being tested?
- UTAA09 cells for infusion, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to Apr 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged between 3~70 (including cut-off values), regardless of gender and race;
- Expected survival time>12 weeks;
- ECOG score 0-2;
- CD19-positive relapsed/refractory B-cell hematolymphatic malignancies;
- Liver and kidney function, cardiopulmonary function meet the following requirements:
- Creatinine ≤ 1.5 ULN;
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- Left ventricular ejection fraction ≥ 45%;
- blood oxygen saturation>91%;
- Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;
- Be able to understand the trial and have signed the informed consent.
Who cannot join
- Those with graft-versus-host disease (GVHD) or requiring long-term systemic immunosuppressants;
- Malignant tumors other than CD19-positive hematologic malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical resection, and breast ductal carcinoma in situ after radical resection;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer outside the normal reference range; Those who are positive for hepatitis C virus (HCV) antibodies and positive for hepatitis C virus (HCV) RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody positive person; Positive for cytomegalovirus (CMV) DNA testing; those who test positive for syphilis;
- Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), and serious arrhythmia;
- Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days before screening, there is active infection or uncontrollable infection requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection);
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- Pregnant or lactating women, female subjects who planned to conceive within 1 year of cell infusion or male subjects whose partner planned pregnancy within 1 year of their cell infusion;
- Screening participants (except for inhalation or local use) who were receiving systemic steroid treatment within 7 days before screening or who were judged by the investigator to require long-term systemic steroid therapy during treatment;
- Participated in other clinical studies within 3 month before screening;
- There was evidence of central nervous system involvement at participant screening;
- Conditions that the investigators considered unsuitable for enrollment.
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
The First Affiliated Hospital of USTC (AnHui Provincial Hospital)
Hefei, Anhui, 230000
Xingbing Wang, MD, +86 18963789012, wangxingbing@ustc.edu.cn
About this study
Official title: Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies.
This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.
Read the detailed description
A single arm open-label clinical study is designed to prelinarily determine the safety, efficacy, the ratio of CD19-positive cells in peripheral blood and cell kinetics after administration of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell hematolymphatic malignancies. All subjects will receive UTAA09 cells infusion.
Primary objective: explore the preliminary safety and efficacy of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell line hematolymphatic malignancies.
Secondary objectives:
- explore the distribution, amplification and survival of UTAA09 cells in vivo after administration of UTAA09 injection;
- explore the ratio of CD19-positive cells in peripheral blood after administration of UTAA09 injection.
- Being tested
- UTAA09 cells for infusion, Fludarabine, Cyclophosphamide
- Keywords
- CD19 target, UCAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UTAA09 cells for infusionBiological
Intravenous injection, dosage:1-10×10^8 CAR+ γδT cells, Cell concentration: 2×10^7 cells/mL.
FludarabineDrug
30 mg/m^2/day×4 days
CyclophosphamideDrug
1000 mg/m^2/day×3 days
| Study group | Role | What they receive |
|---|---|---|
| UTAA09 cells for infusion | Experimental | Off-the-shelf γδT cells with a CD19-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepleting conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day-7~Day-2. Receives: Biological: UTAA09 cells for infusion; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety after UTAA09 injection treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: About 2 years
Evaluation of the efficacy after UTAA09 injection treatment
3-month total response rate (ORR) which includes CR, CRi, and PR will be assessed.
Measured: About 3 months
Secondary outcomes (8)
Assessment of pharmacokinetic (about Cmax)
Assessment of the peak Plasma Concentration (Cmax) of UTAA09 cells amplified in peripheral blood after administration.
Measured: About 2 years
Assessment of pharmacokinetic (about Tmax)
Assessment of the time to reach the highest concentration (Tmax) of UTAA09 cells amplified in peripheral blood after administration.
Measured: About 2 years
Assessment of pharmacokinetic (about AUC0-28d)
Assessment of the Area under the plasma concentration versus time curve (AUC) for 28 days after UTAA09 cells administration.
Measured: About 2 years
Assessment of pharmacokinetic (about AUC0-90d)
Assessment of the Area under the plasma concentration versus time curve (AUC) for 90 days after UTAA09 cells administration.
Measured: About 2 years
Evaluation of Pharmacodynamic
To determine the depletion of peripheral blood CD19-positive B cells at each time point, the concentration of CAR-γδT-associated serum cytokine (CRP, IL-6, etc.).
Measured: About 2 years
To evaluate the efficacy (Overall Survival)
Defined as the time from the start of UTAA09 injection therapy to patient death (due to any cause).
Measured: About 2 years
To evaluate the efficacy (Duration Of Response)
Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause).
Measured: About 2 years
To evaluate the efficacy (Progression Free Survival)
Defined as the time from the start of UTAA09 injection therapy to the first disease progression or recurrence or death due to any cause.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Oct 2023
- Primary completionJul 2026 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19-positive Relapsed or Refractory B-cell MalignanciesStudies of the same condition, open and under way.
- More trials run by PersonGen BioTherapeutics (Suzhou) Co., Ltd.The 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
- Model description
- UTAA09 injection
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Xingbing Wang, MD, Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092047
- Sponsor's protocol ID
- PG-CART-UTAA09-001
- Status last verified
- May 2024
- First submitted
- 7 Oct 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Universal Off-the-shelf Cell Products in Patients With CD19-positive Relapsed/Refractory B-cell Hematolymphatic Malignancies.
- ClinicalTrials.gov ID
- NCT06092047
- Acronym / sponsor ID
- PG-CART-UTAA09-001
- Keywords
- CD19 target, UCAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 23 Oct 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.
This study is designed for exploring the preliminary safety and efficacy of the recombinant allogeneic healthy γδT cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell hematolymphatic malignancies.
Detailed description
A single arm open-label clinical study is designed to prelinarily determine the safety, efficacy, the ratio of CD19-positive cells in peripheral blood and cell kinetics after administration of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell hematolymphatic malignancies. All subjects will receive UTAA09 cells infusion.
Primary objective: explore the preliminary safety and efficacy of UTAA09 injection in patients with CD19-positive relapsed/refractory B-cell line hematolymphatic malignancies.
Secondary objectives:
- explore the distribution, amplification and survival of UTAA09 cells in vivo after administration of UTAA09 injection;
- explore the ratio of CD19-positive cells in peripheral blood after administration of UTAA09 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- UTAA09 injection
| Arm | Type | Receives |
|---|---|---|
| UTAA09 cells for infusion | Experimental | Biological: UTAA09 cells for infusion, Drug: Fludarabine, Drug: CyclophosphamideOff-the-shelf γδT cells with a CD19-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepleting conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day-7~Day-2. |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged between 3~70 (including cut-off values), regardless of gender and race;
- Expected survival time>12 weeks;
- ECOG score 0-2;
- CD19-positive relapsed/refractory B-cell hematolymphatic malignancies;
- Liver and kidney function, cardiopulmonary function meet the following requirements:
Key exclusion criteria (11 listed)
- Those with graft-versus-host disease (GVHD) or requiring long-term systemic immunosuppressants;
- Malignant tumors other than CD19-positive hematologic malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical resection, and breast ductal carcinoma in situ after radical resection;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer outside the normal reference range; Those who are positive for hepatitis C virus (HCV) antibodies and positive for hepatitis C virus (HCV) RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody positive person; Positive for cytomegalovirus (CMV) DNA testing; those who test positive for syphilis;
- Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), and serious arrhythmia;
- Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
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 |
|---|---|---|
| UTAA09 cells for infusionIntravenous injection, dosage:1-10×10^8 CAR+ γδT cells, Cell concentration: 2×10^7 cells/mL. | Biological | UTAA09 cells for infusion |
| Fludarabine30 mg/m^2/day×4 days | Drug | UTAA09 cells for infusion |
| Cyclophosphamide1000 mg/m^2/day×3 days | Drug | UTAA09 cells for infusion |
Primary outcome
Assessment of the safety after UTAA09 injection treatment
Time frame: About 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Evaluation of the efficacy after UTAA09 injection treatment
Time frame: About 3 months
3-month total response rate (ORR) which includes CR, CRi, and PR will be assessed.
8 secondary outcomes
Assessment of pharmacokinetic (about Cmax)
Time frame: About 2 years
Assessment of pharmacokinetic (about Tmax)
Time frame: About 2 years
Assessment of pharmacokinetic (about AUC0-28d)
Time frame: About 2 years
Assessment of pharmacokinetic (about AUC0-90d)
Time frame: About 2 years
Evaluation of Pharmacodynamic
Time frame: About 2 years
To evaluate the efficacy (Overall Survival)
Time frame: About 2 years
To evaluate the efficacy (Duration Of Response)
Time frame: About 2 years
To evaluate the efficacy (Progression Free Survival)
Time frame: About 2 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 16 May 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.
Xingbing Wang, MD principal investigator
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
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 UTAA09 cells for infusion, Fludarabine and Cyclophosphamide in people with CD19-positive Relapsed or Refractory B-cell Malignancies, run by PersonGen BioTherapeutics (Suzhou) 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 10 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: looking for participants now, as of the sponsor's last update on 16 May 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 Xingbing Wang, MD (13856007984, wangxingbing@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety after UTAA09 injection treatment (time frame: About 2 years). 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 16 May 2025.