Status:
RECRUITING
QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
14+ years
Phase:
PHASE1
Brief 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/...
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 3 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06056752
Start Date
September 27 2023
End Date
July 3 2026
Last Update
October 24 2023
Active Locations (1)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230036