Actively Recruiting
QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Led by Anhui Provincial Hospital · Updated on 2023-10-24
10
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older, any gender
- Clinically diagnosed relapsed/refractory B-cell acute lymphoblastic leukemia (excluding extramedullary disease only)
- Failure to achieve complete remission after 2 cycles of standard chemotherapy, or complete remission lasting 12 months or less
- Relapsed/refractory B-ALL unresponsive to one or more salvage treatments
- Relapse after hematopoietic stem cell transplantation including hematological relapse and positive minimal residual disease
- Confirmation of CD19-positive tumor cells by cytology or histology
- Bone marrow containing 5% or more primitive/naïve lymphocytes
- Expected survival time longer than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate vital organ function: left ventricular ejection fraction at least 50%, serum creatinine less than or equal to 1.5 times upper normal limit, liver enzymes no greater than 3 times upper normal limit, total bilirubin no greater than 1.5 times upper normal limit
- Negative pregnancy test for women of childbearing age; agreement to use effective contraception during treatment and for 1 year after
- Prior antitumor therapy toxicity grade 1 or less, or acceptable level according to inclusion/exclusion criteria
- No significant hereditary diseases
- Ability to understand trial requirements and willingness to participate
- Signed informed consent form
You will not qualify if you...
- Uncontrolled active central nervous system leukemia or history of epilepsy or cerebrovascular disease
- Pregnant or breastfeeding women or those not consenting to drug use during and 1 year after treatment
- Presence of other malignant tumors not in remission
- Primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy
- Prior immune cell therapy within 6 months or donor lymphocyte infusion within 6 weeks before enrollment
- Confirmed positive serum anti-FMC63 and donor-specific antibody reactions
- Participation in other clinical trials within 4 weeks prior to enrollment
- Uncontrolled infections or serious diseases including HIV, active hepatitis B or C, congestive heart failure, unstable angina, cardiac arrhythmias, or other physician-assessed risks
- Uncontrollable plasma fluid such as large pleural effusions or ascites
- Stroke or intracranial hemorrhage within 3 months prior to enrollment
- Major surgery or trauma within 28 days prior to enrollment or unresolved major side effects
- Allergy to any ingredient in the cellular product
- Inability or unwillingness to sign informed consent
- Other investigator-determined reasons for unsuitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230036
Actively Recruiting
Research Team
X
Xiaoyu Zhu, Ph.D
CONTACT
G
Guangyu Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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