B-cell Acute Lymphoblastic LeukemiaPhase 1NCT06056752
QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
A Phase 1 study testing QH103 Cell Injection, Fludarabine and Cyclophosphamide in people with B-cell Acute Lymphoblastic Leukemia, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This is a single-arm, single-center, interventional, dose-escalation clinical study designed to evaluate the safety and tolerability of QH103 Cell Injection in the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- QH103 Cell Injection, 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
- 27 Sep 2023to 3 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 is not limited;
- Patients with clinically diagnosed relapsed/refractory B-ALL (except those presenting with extramedullary disease only), including any of the following:
- Failure to obtain CR after 2 cycles of standard chemotherapy;
- First induction of CR, but duration of CR is ≤12 months;
- Relapsed/refractory B-ALL that has failed to respond to the first or multiple salvage treatments;
- Relapse after hematopoietic stem cell transplantation, including hematological relapse and positive micro residual disease (MRD).
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- Cytological or histological confirmation of tumor cell immunophenotyping as CD19 positive;
- Bone marrow with a ratio of ≥5% primitive/naïve lymphocytes (morphology);
- Expected survival time of more than 3 months;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- Vital organ function meets the following requirements: left ventricular ejection fraction ≥50% on echocardiography; serum creatinine≤1.5 × upper limit of normal range (ULN); glutamine aminotransferase, aspartate aminotransferase ≤3 times ULN, total bilirubin ≤1.5 times ULN;
- Pregnancy tests for women of childbearing age should be negative, and both men and women should agree to use effective contraception during treatment and for the following 1 year.
- Toxicity of prior antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or acceptable inclusion/exclusion criteria level.
- No significant hereditary disease;
- Be able to understand the requirements and matters of the trial and be willing to participate in the clinical study as required;
- Sign the trial informed consent form.
Who cannot join
- with uncontrolled active central nervous system leukemia (CNSL) or a history of epilepsy, cerebrovascular disease
- Pregnant or lactating women, or those who do not consent to the use of the drug during and within 1 year after treatment;
- Other malignant tumors not in remission;
- with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
- Patients who have received immune cell therapy within 6 months prior to enrollment and donor lymphocyte infusion within 6 weeks prior to enrollment.
- Patients with confirmed positive serum anti-FMC63 and DSA reactions;
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- Patients who have participated in other clinical trials within 4 weeks prior to enrollment;
- Uncontrolled infectious or other serious diseases, including but not limited to infections (Human Immunodeficiency Virus, acute or chronic active hepatitis B or hepatitis C), congestive heart failure, unstable angina pectoris cardiac arrhythmias, or conditions that the attending physician considers to be an unpredictable risk;
- Uncontrollable plasma fluid, such as large pleural effusions or ascites;
- History of stroke or intracranial hemorrhage within 3 months prior to enrollment;
- Major surgery or trauma within 28 days prior to enrollment, or major side effects from which you have not recovered;
- History of allergy to any of the ingredients in the cellular product;
- Inability to understand or unwillingness to sign the informed consent form;
- Other reasons deemed by the investigator to be unsuitable for the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230036
Zhu Xiaoyu, Ph.D, +86 15255456091, xiaoyuz@ustc.edu.cn
Sun Guangyu, +86 13956970687, sunguangyu_vip@foxmail.com
About this study
Official title: A Dose-escalation Clinical Study of QH103 Cell Injection (CD19 CAR-γδT Cell Injection) in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).
This is a single-arm, single-center, interventional, dose-escalation clinical study designed to evaluate the safety and tolerability of QH103 Cell Injection in the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
Read the detailed description
To evaluate the safety and tolerability of QH103 Cell Injection in the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia, and to evaluate dose-limiting toxicity and maximum tolerated dose.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- QH103 Cell Injection, Fludarabine, Cyclophosphamide
- Keywords
- B-ALL, Allogenic CAR-γδT Cell, CD19, cell therapy
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QH103 Cell InjectionBiological
dose escalation (3+3) : dose 1 (3×10^8CAR+cells) ,dose 2 (1 × 10^9 CAR+cells）,dose 3 (3 × 10^9CAR+cells)
FludarabineDrug
Also called Fludarabine Phosphate for Injection
Intravenous fludarabine on days-5~-2,the infusion dose is adjusted according to the subject's condition
CyclophosphamideDrug
Also called Cyclophosphamide for Injection
Intravenous cyclophosphamide on days -5~-3, the infusion dose is adjusted according to the subject's condition
| Study group | Role | What they receive |
|---|---|---|
| Patients with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia | Experimental | A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells Receives: Biological: QH103 Cell Injection; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
AE is defined as any adverse medical event from the date of leukapheresis to 12 months after QH103 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
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:
The development of Grade (G) III-IV acute GVHD according to the Mount Sinai Acute GVHD International Consortium criteria; The development of G3 or higher grade CRS lasting > 2 weeks; Any QH103 cells-related AE requiring intubation; All G4 non-hematologic toxicities. Symptoms of GVHD include but are not limited to skin rash, enterocolitis with diarrhea, liver dysfunction with jaundice, fever, weight loss, etc.
Measured: First infusion date of QH103 cells to 28 days end cell infusion
Maximum tolerated dose (MTD)
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
Measured: 28 days
Secondary outcomes (5)
Overall Survival (OS）
OS is defined as the time from QH103 cells infusion to the date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date.
Measured: 12 months
Progression Free Survival (PFS)
PFS is defined as the time from the QH103 cells infusion date to the date of disease progression assessed by investigators assessment, or death any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Measured: 12 months
Pharmacokinetics: Persistence of the QH103 cells
Persistence of the QH103 cells assessed by number in peripheral blood.
Measured: 28 days
Pharmacodynamics: Peak level of cytokines in serum
The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α) etc. Peak was defined as the maximum post-baseline level of the cytokine.
Measured: 28 days
Overall Response Rate(ORR)
Proportion of subjects with CR (complete response) and CRi (complete response with incomplete hemocyte recovery)
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 posted28 Sep 2023
- Study start27 Sep 2023
- Primary completion3 Jul 2025 (estimated)
- Study completion3 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiaoyu Zhu, Anhui Provincial Hospital
- Investigators
- Xiaoyu Zhu, Ph.D, Principal investigator, Director of Hematology Department, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056752
- Sponsor's protocol ID
- QH10302-B-01(0)
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 24 Oct 2023
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation Clinical Study of QH103 Cell Injection (CD19 CAR-γδT Cell Injection) in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).
- ClinicalTrials.gov ID
- NCT06056752
- Acronym / sponsor ID
- QH10302-B-01(0)
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Keywords
- B-ALL, Allogenic CAR-γδT Cell, CD19, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 3 Jul 2025 (estimated)
- Study completion
- 3 Jul 2026 (estimated)
- First posted
- 28 Sep 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 is a single-arm, single-center, interventional, dose-escalation clinical study designed to evaluate the safety and tolerability of QH103 Cell Injection in the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
Detailed description
To evaluate the safety and tolerability of QH103 Cell Injection in the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia, and to evaluate dose-limiting toxicity and maximum tolerated dose.
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 B-cell acute lymphoblastic leukemia | Experimental | Biological: QH103 Cell Injection, Drug: Fludarabine, Drug: CyclophosphamideA conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells |
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 is not limited;
- Patients with clinically diagnosed relapsed/refractory B-ALL (except those presenting with extramedullary disease only), including any of the following:
- Cytological or histological confirmation of tumor cell immunophenotyping as CD19 positive;
- Bone marrow with a ratio of ≥5% primitive/naïve lymphocytes (morphology);
- Expected survival time of more than 3 months;
Key exclusion criteria (14 listed)
- with uncontrolled active central nervous system leukemia (CNSL) or a history of epilepsy, cerebrovascular disease
- Pregnant or lactating women, or those who do not consent to the use of the drug during and within 1 year after treatment;
- Other malignant tumors not in remission;
- with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
- Patients who have received immune cell therapy within 6 months prior to enrollment and donor lymphocyte infusion within 6 weeks prior to 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 |
|---|---|---|
| QH103 Cell Injectiondose escalation (3+3) : dose 1 (3×10^8CAR+cells) ,dose 2 (1 × 10^9 CAR+cells）,dose 3 (3 × 10^9CAR+cells) | Biological | Patients with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia |
| FludarabineAlso: Fludarabine Phosphate for InjectionIntravenous fludarabine on days-5~-2,the infusion dose is adjusted according to the subject's condition | Drug | Patients with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia |
| CyclophosphamideAlso: Cyclophosphamide for InjectionIntravenous cyclophosphamide on days -5~-3, the infusion dose is adjusted according to the subject's condition | Drug | Patients with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: 12 months
AE is defined as any adverse medical event from the date of leukapheresis to 12 months after QH103 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: First infusion date of QH103 cells to 28 days end cell infusion
DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion: The development of Grade (G) III-IV acute GVHD according to the Mount Sinai Acute GVHD International Consortium criteria; The development of G3 or higher grade CRS lasting > 2 weeks; Any QH103 cells-related AE requiring intubation; All G4 non-hematologic toxicities. Symptoms of GVHD include but are not limited to skin rash, enterocolitis with diarrhea, liver dysfunction with jaundice, fever, weight loss, etc.
Maximum tolerated dose (MTD)
Time frame: 28 days
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
5 secondary outcomes
Overall Survival (OS）
Time frame: 12 months
Progression Free Survival (PFS)
Time frame: 12 months
Pharmacokinetics: Persistence of the QH103 cells
Time frame: 28 days
Pharmacodynamics: Peak level of cytokines in serum
Time frame: 28 days
Overall Response Rate(ORR)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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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. This study is not recruiting at the moment.
Xiaoyu Zhu, Ph.D principal investigator
Director of Hematology Department, Anhui Provincial Hospital
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 QH103 Cell Injection, Fludarabine and Cyclophosphamide in people with B-cell Acute Lymphoblastic Leukemia, run by Anhui Provincial Hospital 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 14 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu, Ph.D (+86 15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: 12 months). The study lists 3 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 Oct 2023.