qh103 cell injection for the treatment of relapsed/refractory b-cell acute lymphoblastic leukemia

Conditions: B-cell Acute Lymphoblastic Leukemia

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.

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.

Eligibility criteria:
inclusion criteria: 1. age ≥14 years, gender is not limited; 2. patients with clinically diagnosed relapsed/refractory b-all (except those presenting with extramedullary disease only), including any of the following: 1. failure to obtain cr after 2 cycles of standard chemotherapy; 2. first induction of cr, but duration of cr is ≤12 months; 3. relapsed/refractory b-all that has failed to respond to the first or multiple salvage treatments; 4. relapse after hematopoietic stem cell transplantation, including hematological relapse and positive micro residual disease (mrd). 3. cytological or histological confirmation of tumor cell immunophenotyping as cd19 positive; 4. bone marrow with a ratio of ≥5% primitive/naïve lymphocytes (morphology); 5. expected survival time of more than 3 months; 6. eastern cooperative oncology group (ecog) score of 0-2; 7. 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; 8. 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. 9. toxicity of prior antitumor therapy ≤ grade 1 (according to ctcae version 5.0) or acceptable inclusion/exclusion criteria level. 10. no significant hereditary disease; 11. be able to understand the requirements and matters of the trial and be willing to participate in the clinical study as required; 12. sign the trial informed consent form. exclusion criteria: 1. with uncontrolled active central nervous system leukemia (cnsl) or a history of epilepsy, cerebrovascular disease 2. pregnant or lactating women, or those who do not consent to the use of the drug during and within 1 year after treatment; 3. other malignant tumors not in remission; 4. with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy; 5. patients who have received immune cell therapy within 6 months prior to enrollment and donor lymphocyte infusion within 6 weeks prior to enrollment. 6. patients with confirmed positive serum anti-fmc63 and dsa reactions; 7. patients who have participated in other clinical trials within 4 weeks prior to enrollment; 8. 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; 9. uncontrollable plasma fluid, such as large pleural effusions or ascites; 10. history of stroke or intracranial hemorrhage within 3 months prior to enrollment; 11. major surgery or trauma within 28 days prior to enrollment, or major side effects from which you have not recovered; 12. history of allergy to any of the ingredients in the cellular product; 13. inability to understand or unwillingness to sign the informed consent form; 14. other reasons deemed by the investigator to be unsuitable for the clinical trial.

Keywords: b-all allogenic car-γδt cell cd19 cell therapy