Relapsed/Refractory CD19-positive B-ALLPhase 1NCT07491263
Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia
A Phase 1 study testing Cyclophosphamide, Fludarabine and QH103 Cell Injection in people with Relapsed/Refractory CD19-positive B-ALL, run by Fujian Medical University at 1 site in China.
Trial summary
This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Relapsed/Refractory CD19-positive B-ALL
- What is being tested?
- Cyclophosphamide, Fludarabine and QH103 Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2028
- Phase
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 14 years, gender unrestricted;
- Clinically diagnosed with relapsed/refractory acute B-lymphoblastic leukemia, with bone marrow blast/immature lymphocyte proportion ≥5% (morphology) (excluding cases with isolated extramedullary involvement), meeting any of the following criteria:
- Failure to achieve CR after 2 cycles of standard chemotherapy;
- Initial induction achieved CR, but CR duration ≤12 months;
- Relapsed/refractory B-ALL refractory to first or multiple salvage therapies;
- Post-hematopoietic stem cell transplantation relapse, including hematological relapse and minimal residual disease (MRD) positivity;
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- Patients for whom no standard therapy exists.
- Cytology or histology confirms tumor cell immunophenotype as CD19-positive;
- Expected survival time exceeding 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Key organ functions meeting the following criteria: left ventricular ejection fraction ≥50% by echocardiography; serum creatinine ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN; total bilirubin ≤1.5 × ULN;
- Negative pregnancy test for women of childbearing potential; both males and females agree to use effective contraception during treatment and for 1 year thereafter;
- Toxicity from prior anti-tumor therapy ≤ Grade 1 (according to CTCAE v5.0) or at an acceptable level per inclusion/exclusion criteria;
- No significant hereditary diseases;
- Able to comprehend the trial requirements and procedures, and willing to participate in the clinical study as required;
- Signed informed consent form for the trial
Who cannot join
- Presence of central nervous system (CNS) involvement or a clinically significant history of CNS diseases, such as epilepsy and cerebrovascular diseases;
- Pregnant or lactating women, or women who disagree to use effective contraception during treatment and within 1 year after treatment;
- Other malignancies that are not in remission;
- Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
- Patients who have received allogeneic immune cell therapy within 6 months before enrollment, or donor lymphocyte infusion within 6 weeks before enrollment;
- Confirmed positive anti-FMC63 and DSA responses in the patient's serum;
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- Patients who have participated in other clinical trials within 4 weeks before enrollment;
- Uncontrolled infectious diseases or other serious conditions, including but not limited to infections (human immunodeficiency virus, acute or chronic active hepatitis B or C), congestive heart failure, unstable angina, arrhythmia, or conditions considered by the treating physician to pose unpredictable risks;
- History of stroke or intracranial hemorrhage within 3 months before enrollment;
- Major surgery or trauma within 28 days before enrollment, or main side effects not yet recovered;
- History of allergy to any component of the cell product;
- Inability to understand or unwillingness to sign the informed consent form;
- Other reasons deemed by the researchers as unsuitable for the clinical trial.
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
The first affiliated hospital of fujian medical university
Fuzhou, Fujian, 350005
Ting Yang, +86 13950210357, yang.hopeting@gmail.com
About this study
This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.
- Conditions
- Relapsed/Refractory CD19-positive B-ALL
- Being tested
- Cyclophosphamide, Fludarabine, QH103 Cell Injection
- Keywords
- CD19, CAR-γδT, cell therapy
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called CD19CAR-γδT cell injection
Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days).
FludarabineDrug
Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg/m² administered 3 days).
QH103 Cell InjectionBiological
Also called CD19CAR-γδT cell injection
Biological: CD19 CAR-γδT cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10^8 CAR+cells) ,dose 2 (3× 10^8 CAR+cells).
| Study group | Role | What they receive |
|---|---|---|
| Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia | Experimental | A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells
Interventions:
Biological: QH103 Cell Injection Drug: Fludarabine Drug: Cyclophosphamide Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: QH103 Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Measured: 12 months
Incidence of Dose-Limiting Toxicities (DLTs)
DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.
Measured: 28 days
Secondary outcomes (3)
PK(Pharmacokinetics):Number and Copy Number of CD19 CAR-γδT cells
Measured: 12 months
PK: Persistence of CD19 CAR-γδT
Measured: 12 months
PD(Pharmacodynamics) ：Changes in Various Cytokine Levels (IL-2, IL-4, IL-6, IFN-γ, TNF α, etc.) from Baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory CD19-positive B-ALLStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491263
- Sponsor's protocol ID
- QH10309-NHB-01（0）
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07491263
- Acronym / sponsor ID
- QH10309-NHB-01（0）
- Conditions
- Relapsed/Refractory CD19-positive B-ALL
- Keywords
- CD19, CAR-γδT, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Mar 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 study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: QH103 Cell InjectionA conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells Interventions: Biological: QH103 Cell Injection Drug: Fludarabine Drug: Cyclophosphamide |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Age > 14 years, gender unrestricted;
- Clinically diagnosed with relapsed/refractory acute B-lymphoblastic leukemia, with bone marrow blast/immature lymphocyte proportion ≥5% (morphology) (excluding cases with isolated extramedullary involvement), meeting any of the following criteria:
- Cytology or histology confirms tumor cell immunophenotype as CD19-positive;
- Expected survival time exceeding 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
Key exclusion criteria (13 listed)
- Presence of central nervous system (CNS) involvement or a clinically significant history of CNS diseases, such as epilepsy and cerebrovascular diseases;
- Pregnant or lactating women, or women who disagree to use effective contraception during treatment and within 1 year after treatment;
- Other malignancies that are not in remission;
- Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
- Patients who have received allogeneic immune cell therapy within 6 months before enrollment, or donor lymphocyte infusion within 6 weeks before enrollment;
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 |
|---|---|---|
| CyclophosphamideAlso: CD19CAR-γδT cell injectionEligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days). | Drug | Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia |
| FludarabineEligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg/m² administered 3 days). | Drug | Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia |
| QH103 Cell InjectionAlso: CD19CAR-γδT cell injectionBiological: CD19 CAR-γδT cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10^8 CAR+cells) ,dose 2 (3× 10^8 CAR+cells). | Biological | Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia |
Primary outcome
Adverse Event
Time frame: 12 months
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 28 days
DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.
3 secondary outcomes
PK(Pharmacokinetics):Number and Copy Number of CD19 CAR-γδT cells
Time frame: 12 months
PK: Persistence of CD19 CAR-γδT
Time frame: 12 months
PD(Pharmacodynamics) ：Changes in Various Cytokine Levels (IL-2, IL-4, IL-6, IFN-γ, TNF α, etc.) from Baseline
Time frame: 12 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 24 Mar 2026.
- Individual participant dataSharing planned: No. Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.
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RecruitingPhase 2
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Fludarabine and QH103 Cell Injection in people with Relapsed/Refractory CD19-positive B-ALL, run by Fujian Medical University 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 16 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: opening soon, as of the sponsor's last update on 24 Mar 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?
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?
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 Ting Yang (+86 13950210357, yang.hopeting@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: 12 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 24 Mar 2026.