- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06056752
QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Xiaoyu Zhu, Ph.D
- Phone Number: +86 15255456091
- Email: xiaoyuz@ustc.edu.cn
Study Contact Backup
- Name: Guangyu Sun
- Phone Number: +86 13956970687
- Email: sunguangyu_vip@foxmail.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230036
- Recruiting
- Anhui Provincial Hospital
-
Contact:
- Zhu Xiaoyu, Ph.D
- Phone Number: +86 15255456091
- Email: xiaoyuz@ustc.edu.cn
-
Contact:
- Sun Guangyu
- Phone Number: +86 13956970687
- Email: sunguangyu_vip@foxmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia
A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells
|
dose escalation (3+3) : dose 1 (3×10^8CAR+cells) ,dose 2 (1 × 10^9 CAR+cells),dose 3 (3 × 10^9CAR+cells)
Intravenous fludarabine on days-5~-2,the infusion dose is adjusted according to the subject's condition
Other Names:
Intravenous cyclophosphamide on days -5~-3, the infusion dose is adjusted according to the subject's condition
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
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. |
First infusion date of QH103 cells to 28 days end cell infusion
|
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.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 12 months
|
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.
|
12 months
|
Progression Free Survival (PFS)
Time Frame: 12 months
|
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.
|
12 months
|
Pharmacokinetics: Persistence of the QH103 cells
Time Frame: 28 days
|
Persistence of the QH103 cells assessed by number in peripheral blood.
|
28 days
|
Pharmacodynamics: Peak level of cytokines in serum
Time Frame: 28 days
|
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.
|
28 days
|
Overall Response Rate(ORR)
Time Frame: 12 months
|
Proportion of subjects with CR (complete response) and CRi (complete response with incomplete hemocyte recovery)
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaoyu Zhu, Ph.D, Director of Hematology Department, Anhui Provincial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
- Fludarabine phosphate
Other Study ID Numbers
- QH10302-B-01(0)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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