T-ALLEarly Phase 1NCT06849401
The Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed/Refractory Acute T-lymphoblastic Leukemia
A Early Phase 1 study testing VGO-Cs01p in people with T-ALL, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
To learn if the VGO-Cs01p can help to control CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL) in children. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- T-ALL
- What is being tested?
- VGO-Cs01p
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Oct 2026
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥2 and ≤18 years old, male or female;
- Subjects who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) according to the standards of the NCCN Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2024.V6);
- Meets the criteria for recurrent or refractory T-ALL, including: a) Recurrent: Reappearance of blasts in peripheral blood or bone marrow (>25%) after complete remission or occurrence of extramedullary disease, and ineffectiveness of other treatments； b) Primary Refractory: Appearance of blasts in bone marrow ≥5% after 2 months standard induction chemotherapy, and no other treatment can be used as judged by the investigator;
- After one cycle of other treatments (such as Olverembatinib combined with APG-125), the blasts remain≥5%;
- Cell immunophenotyping confirmation of CD7 positive blasts >80%;
- Estimated survival period >12 weeks;
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- Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 or KPS > 60;
- Left ventricular ejection fraction ≥50%;
- Pulmonary function ≤ Grade 1 dyspnea (CTCAE v5.0), normal oxygen saturation without oxygen supplementation;
- TBil ≤ 3×ULN, AST and ALT ≤ 5×ULN, creatinine ≤ 1.6 mg/dl within 1 week prior to enrollment;
- Negative serum pregnancy test for fertile women; fertile non-abstinent female patients must agree to use an effective contraceptive method from screening to 1 year after cell infusion. Fertile male patients' partners must agree to use effective contraception from screening to 1 year after cell infusion, and should not donate semen or sperm throughout the study;
- The subject or their legal guardian voluntarily participates in the study, understands the information, purpose, and risks described in the informed consent form, and can provide a signed and dated informed consent form;
- The subject and/or their parents or their legal guardian should voluntary and able to comply with all requirements of the trial.
Who cannot join
- Extramedullary involvement of the central nervous system or testicular at screening.
- Patients with a history of severe CNS diseases, such as uncontrolled seizures, stroke, severe brain damage resulting in speech impairment, psychiatric disorders, etc;
- NYHA functional class III or IV heart failure;
- Presence of disseminated intravascular coagulation;
- Presence of severe autoimmune diseases or immune deficiency diseases;
- Active GVHD requiring systemic treatment;
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- Presence of other severe diseases, presence of gastrointestinal ulcers or active gastrointestinal bleeding, currently undergoing anticoagulant or antiplatelet therapy, or judged by the investigator to pose unacceptable surgical or anesthesia risks;
- Currently receiving systemic steroids or other immunosuppressive therapy prior to screening, and still need long-term use after enrollment as judged by the investigator (excluding inhaled or local use);
- History or concurrent active malignant tumors within 3 years prior to enrollment;
- Active HBV or HCV infection (HBV-DNA positive or HCV-RNA positive), HIV positive, or positive syphilis test;
- Other severe or persistent active infections;
- Adverse events related to previous systemic immunotherapy (including other investigational drugs or medical device interventions) prior to enrollment have not reduced to grade 1 severity or returned to baseline;
- Platelet count remains low after intervention treatment (meeting clinical transfusion criteria) prior to enrollment；
- Discontinuation of immunosuppressive agents for less than 2 weeks;
- Participation in CAR-T cell therapy or gene therapy at any time prior to screening;
- History of allergy to any component of the study product;
- Vaccination or any surgery within the 4 weeks prior to screening;
- Other situations as judged by the investigator may increase the subject's risk or interfere with study;
- Pregnant or breastfeeding women;
- Individuals assessed by the investigator to have potential hidden risks of disputes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Open Label Clinical Study to Evaluate the Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed/Refractory Acute T-lymphoblastic Leukemia
To learn if the VGO-Cs01p can help to control CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL) in children.
Read the detailed description
This is a single-arm, open label, IIT clinical trial to evaluate the safety and efficacy of CD7 CAR NK cells in subjects with CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL). 5~9 subjects plan to be enrolled. In this study, safety and efficacy results will be used for dose escalation design at the same time, and three initial dose groups are set up. All subjects will be followed up to 12 months after infusion.
- Conditions
- T-ALL
- Being tested
- VGO-Cs01p
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGO-Cs01pBiological
Off-the-shelf NK cell products derived from human embryonic stem cells (hESCs)
| Study group | Role | What they receive |
|---|---|---|
| VGO-Cs01p | Experimental | Up to three sequential VGO-Cs01p dose levels （4e7、1.2e8、3.6e8 CAR-NK cells/kg）are planned. Each subject will accept six doses of VGO-Cs01p Receives: Biological: VGO-Cs01p |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product; the event will not need to have a causal relationship with the treatment.
Measured: 1 year post the first VGO-Cs01p infusion
Secondary outcomes (11)
ORR（Objective response rate）
Includes CR (complete response)/ CRh (CR with partial hematological recovery) /CRi (CR with incomplete hematological recovery)/PR（partial response）.
Measured: 28 days and 1 year post the first VGO-Cs01p infusion
MRD (Minimal/Measurable Residual Diseas)
Minimal/Measurable Residual Disease negative response rate
Measured: 1 year post the first VGO-Cs01p infusion
DOR (Duration of response)
DOR is defined as the time from the first assessment of CR/CRh/CRi to relapse or death in clinical remission.
Measured: 1 year post the first VGO-Cs01p infusion
LFS (Leukemia-Free Survival)
Defined as the time from clinical remission (CR/CRh/CRi) to relapse or death in clinical remission.
Measured: 1 year post the first VGO-Cs01p infusion
OS (Overall survival)
Overall survival was defined as the time from the first infusion until the subject died or lost to follow-up for any cause.
Measured: 1 year post the first VGO-Cs01p infusion
PK parameters of VGO-Cs01p
Cmax
Measured: 1 year post the first VGO-Cs01p infusion
Absolute value of CD7+ cells in peripheral blood
PD parameters
Measured: 1 year post the first VGO-Cs01p infusion
Immunogenicity
The number of subjects with antibodies to VGO-Cs01p and the antibody titer.
Measured: 1 year post the first VGO-Cs01p infusion
PK parameters of VGO-Cs01p
Tmax
Measured: 1 year post the first VGO-Cs01p infusion
PK parameters of VGO-Cs01p
AUC0-28
Measured: 1 year post the first VGO-Cs01p infusion
Proportion of CD7+ cells in peripheral blood
PD parameters
Measured: 1 year post the first VGO-Cs01p infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study startJul 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-ALLStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Vitalgen BioPharma Co., Ltd.
- Responsible party
- Principal investigator, Hui Zhang, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849401
- Sponsor's protocol ID
- VGO-Cs01p-001
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other researchers when VGO-Cs01p is fully approved.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open Label Clinical Study to Evaluate the Safety and Efficacy of VGO-Cs01p in Patients With CD7-positive Relapsed/Refractory Acute T-lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06849401
- Acronym / sponsor ID
- VGO-Cs01p-001
- Conditions
- T-ALL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Vitalgen BioPharma Co., Ltd.
- Study start
- Jul 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Feb 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.
To learn if the VGO-Cs01p can help to control CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL) in children.
Detailed description
This is a single-arm, open label, IIT clinical trial to evaluate the safety and efficacy of CD7 CAR NK cells in subjects with CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL). 5~9 subjects plan to be enrolled. In this study, safety and efficacy results will be used for dose escalation design at the same time, and three initial dose groups are set up. All subjects will be followed up to 12 months after infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VGO-Cs01p | Experimental | Biological: VGO-Cs01pUp to three sequential VGO-Cs01p dose levels （4e7、1.2e8、3.6e8 CAR-NK cells/kg）are planned. Each subject will accept six doses of VGO-Cs01p |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Age ≥2 and ≤18 years old, male or female;
- Subjects who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) according to the standards of the NCCN Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2024.V6);
- Meets the criteria for recurrent or refractory T-ALL, including: a) Recurrent: Reappearance of blasts in peripheral blood or bone marrow (>25%) after complete remission or occurrence of extramedullary disease, and ineffectiveness of other treatments； b) Primary Refractory: Appearance of blasts in bone marrow ≥5% after 2 months standard induction chemotherapy, and no other treatment can be used as judged by the investigator;
- After one cycle of other treatments (such as Olverembatinib combined with APG-125), the blasts remain≥5%;
- Cell immunophenotyping confirmation of CD7 positive blasts >80%;
Key exclusion criteria (20 listed)
- Extramedullary involvement of the central nervous system or testicular at screening.
- Patients with a history of severe CNS diseases, such as uncontrolled seizures, stroke, severe brain damage resulting in speech impairment, psychiatric disorders, etc;
- NYHA functional class III or IV heart failure;
- Presence of disseminated intravascular coagulation;
- Presence of severe autoimmune diseases or immune deficiency diseases;
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 |
|---|---|---|
| VGO-Cs01pOff-the-shelf NK cell products derived from human embryonic stem cells (hESCs) | Biological | VGO-Cs01p |
Primary outcome
Incidence and severity of adverse events
Time frame: 1 year post the first VGO-Cs01p infusion
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product; the event will not need to have a causal relationship with the treatment.
11 secondary outcomes
ORR（Objective response rate）
Time frame: 28 days and 1 year post the first VGO-Cs01p infusion
MRD (Minimal/Measurable Residual Diseas)
Time frame: 1 year post the first VGO-Cs01p infusion
DOR (Duration of response)
Time frame: 1 year post the first VGO-Cs01p infusion
LFS (Leukemia-Free Survival)
Time frame: 1 year post the first VGO-Cs01p infusion
OS (Overall survival)
Time frame: 1 year post the first VGO-Cs01p infusion
PK parameters of VGO-Cs01p
Time frame: 1 year post the first VGO-Cs01p infusion
Absolute value of CD7+ cells in peripheral blood
Time frame: 1 year post the first VGO-Cs01p infusion
Immunogenicity
Time frame: 1 year post the first VGO-Cs01p infusion
PK parameters of VGO-Cs01p
Time frame: 1 year post the first VGO-Cs01p infusion
PK parameters of VGO-Cs01p
Time frame: 1 year post the first VGO-Cs01p infusion
Proportion of CD7+ cells in peripheral blood
Time frame: 1 year post the first VGO-Cs01p infusion
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 15 May 2025.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers when VGO-Cs01p is fully approved.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing VGO-Cs01p in people with T-ALL, run by Shanghai Jiao Tong University School of Medicine.
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 20 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: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hui Zhang (15821333007, zhang-hui@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: 1 year post the first VGO-Cs01p infusion). 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 15 May 2025.