Hematolymphoid MalignanciesEarly Phase 1NCT07338604
Clinical Study of UTAA07 Injection in the Treatment of Hematologic and Lymphatic Systemic Malignancies
A Early Phase 1 study testing CAR-T cell infusion and UTAA07 injection in people with Hematolymphoid Malignancies, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, open-label study designed to evaluate the safety, tolerability and cellular pharmacokinetic profiles of UTAA07 Injection. It also aims to preliminarily assess the efficacy of the investigational drug in subjects with relapsed/refractory hematolymphoid malignancies, so as to identify the optimal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematolymphoid Malignancies
- What is being tested?
- CAR-T cell infusion and UTAA07 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years, regardless of gender.
- Expected survival time ≥ 3 months.
- ECOG performance status score of 0-1.
- Confirmed diagnosis of relapsed/refractory CD7-positive hematolymphoid malignancies at screening.
- Coagulation function, liver and kidney function, and cardiopulmonary function meeting the requirements.
- Ability to understand the trial and signed informed consent form.
Who cannot join
- A history of malignant tumors other than hematolymphoid malignancies within 5 years prior to screening, excluding carcinoma in situ.
- Positive results for virological tests or syphilis.
- Severe cardiac diseases.
- Unstable systemic diseases as determined by the investigator.
- Active or uncontrolled infections requiring systemic treatment within 7 days prior to screening, excluding mild urinary and reproductive system infections and upper respiratory tract infections.
- Pregnant or lactating women; female subjects planning to become pregnant within 2 years after cell infusion; or male subjects whose partners plan to become pregnant within 2 years after the subject's cell infusion.
Show all 13Show fewer
- Subjects receiving systemic corticosteroid therapy within 7 days prior to screening, or those judged by the investigator to require long-term systemic corticosteroid therapy during the trial period, excluding inhaled or topical administration.
- Participation in other clinical studies within 1 month prior to screening.
- Evidence of central nervous system (CNS) involvement at screening, such as detection of tumor cells in cerebrospinal fluid (CSF) or imaging findings suggestive of CNS infiltration.
- Patients requiring long-term use of immunosuppressants as determined by the investigator at screening.
- A history of epilepsy or other central nervous system diseases.
- Patients with primary immunodeficiency diseases.
- Other circumstances deemed inappropriate for enrollment by the investigator.
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 Soochow University
Suzhou, Jiangsu, 215000
Yang Xu, MD, +86 13732628683, xuyang1020@126.com
About this study
Official title: Clinical Study of UTAA07 Injection in the Treatment of CD7 Positive Adult Relapsed/Refractory Hematologic and Lymphatic Systemic Malignancies
This is a single-arm, open-label study designed to evaluate the safety, tolerability and cellular pharmacokinetic profiles of UTAA07 Injection. It also aims to preliminarily assess the efficacy of the investigational drug in subjects with relapsed/refractory hematolymphoid malignancies, so as to identify the optimal dose for subsequent formal clinical trials.
Read the detailed description
This is a single-arm, open-label study designed to investigate the safety, tolerability, and cellular kinetic characteristics of the investigational product. Additionally, it aims to preliminarily observe the efficacy of the investigational product in subjects with relapsed/refractory hematological and lymphoid malignancies, so as to explore the optimal dose for formal clinical applications.
Three dose cohorts are planned, namely 2×10⁹ CAR-γδT cells, 4×10⁹ CAR-γδT cells, and 6×10⁹ CAR-γδT cells. Additional dose cohorts may be added at the discretion of the investigator and/or collaborating institutions. The study will adopt a 3+3 dose escalation/de-escalation schema.
- Conditions
- Hematolymphoid Malignancies
- Being tested
- CAR-T cell infusion, UTAA07 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cell infusionDrug
CAR-T cell infusion
UTAA07 injectionDrug
UTAA07 Injection is a chimeric antigen receptor (CAR)-engineered γδ T-cell product that targets the CD7 antigen expressed on the surface of tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| UTAA07 injection | Experimental | Not described Receives: Drug: CAR-T cell infusion; Drug: UTAA07 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Types, frequencies, and severity of adverse events (AEs) and laboratory abnormalities (in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0)
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 Jan 2026
- Study start12 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematolymphoid 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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338604
- Sponsor's protocol ID
- PG-004-3
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
You MJ, Medeiros LJ, Hsi ED. T-lymphoblastic leukemia/lymphoma. Am J Clin Pathol. 2015 Sep;144(3):411-22. doi: 10.1309/AJCPMF03LVSBLHPJ.
PubMed 26276771
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of UTAA07 Injection in the Treatment of CD7 Positive Adult Relapsed/Refractory Hematologic and Lymphatic Systemic Malignancies
- ClinicalTrials.gov ID
- NCT07338604
- Acronym / sponsor ID
- PG-004-3
- Conditions
- Hematolymphoid Malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 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.
This is a single-arm, open-label study designed to evaluate the safety, tolerability and cellular pharmacokinetic profiles of UTAA07 Injection. It also aims to preliminarily assess the efficacy of the investigational drug in subjects with relapsed/refractory hematolymphoid malignancies, so as to identify the optimal dose for subsequent formal clinical trials.
Detailed description
This is a single-arm, open-label study designed to investigate the safety, tolerability, and cellular kinetic characteristics of the investigational product. Additionally, it aims to preliminarily observe the efficacy of the investigational product in subjects with relapsed/refractory hematological and lymphoid malignancies, so as to explore the optimal dose for formal clinical applications.
Three dose cohorts are planned, namely 2×10⁹ CAR-γδT cells, 4×10⁹ CAR-γδT cells, and 6×10⁹ CAR-γδT cells. Additional dose cohorts may be added at the discretion of the investigator and/or collaborating institutions. The study will adopt a 3+3 dose escalation/de-escalation schema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UTAA07 injection | Experimental | Drug: CAR-T cell infusion, Drug: UTAA07 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years, regardless of gender.
- Expected survival time ≥ 3 months.
- ECOG performance status score of 0-1.
- Confirmed diagnosis of relapsed/refractory CD7-positive hematolymphoid malignancies at screening.
- Coagulation function, liver and kidney function, and cardiopulmonary function meeting the requirements.
Key exclusion criteria (13 listed)
- A history of malignant tumors other than hematolymphoid malignancies within 5 years prior to screening, excluding carcinoma in situ.
- Positive results for virological tests or syphilis.
- Severe cardiac diseases.
- Unstable systemic diseases as determined by the investigator.
- Active or uncontrolled infections requiring systemic treatment within 7 days prior to screening, excluding mild urinary and reproductive system infections and upper respiratory tract infections.
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 |
|---|---|---|
| CAR-T cell infusionCAR-T cell infusion | Drug | UTAA07 injection |
| UTAA07 injectionUTAA07 Injection is a chimeric antigen receptor (CAR)-engineered γδ T-cell product that targets the CD7 antigen expressed on the surface of tumor cells. | Drug | UTAA07 injection |
Primary outcome
Adverse Events
Time frame: 24 months
Types, frequencies, and severity of adverse events (AEs) and laboratory abnormalities (in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0)
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 14 Jan 2026.
- Background: PubMed 26276771You MJ, Medeiros LJ, Hsi ED. T-lymphoblastic leukemia/lymphoma. Am J Clin Pathol. 2015 Sep;144(3):411-22. doi: 10.1309/AJCPMF03LVSBLHPJ.
- Individual participant dataSharing planned: No
Related trials for Hematolymphoid Malignancies
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Not yet recruiting
Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies
Oral Mucositis Due to Chemotherapy, Hematolymphoid Malignancies
Not yet recruiting
This Clinical Trial is a Single-arm, Non-randomized Pilot Trial to Determine the Safety of Administering Autologous Anti-C19 Cells (ARI-0001) and the Feasibility of Local CAR-T Cell Production in Patients Over 18 Years of Age With Relapsed/Refractory (R/R) CD19+ Hematologic Malignancies, Including R
Adult B-cell Acute Lymphoblastic Leukemia, Follicular Lymphoma (FL)
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 Early Phase 1 study testing CAR-T cell infusion and UTAA07 injection in people with Hematolymphoid 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 6 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: looking for participants now, as of the sponsor's last update on 14 Jan 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?
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 Yang Xu, MD (+86 13732628683, xuyang1020@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07338604, which also lists 1 linked publication.
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 14 Jan 2026.