A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Ce… (NCT07470073) | Clinical Trial Compass
RecruitingEarly Phase 1
A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults
China18 participantsStarted 2026-04-01
Plain-language summary
This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.
Who can participate
Age range12 Years – 75 Years
SexALL
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Inclusion criteria
✓. The patients who did not achieve complete remission by the standardized induction chemotherapy, or early relapse (\<12 months) after complete remission, or late relapse (≥ 12 months) after complete remission, and did not achieve complete remission by the standardized one course induction chemotherapy (except for the patients with late relapse who did not have a better treatment or did not tolerate other treatments according to the investigator's assessment), relapsed after 2 or more CR or CRI;
✓. For ph+all patients, in addition to receiving standard induction chemotherapy, they should also receive at least two kinds of TKI treatment without complete remission or relapse after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment, or those with T315I mutation do not need to receive TKI treatment);
✓. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; In case of hepatobiliary invasion: AST and alt ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;
✓. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
✓. Oxygen saturation in non oxygen inhalation state was \> 91%;
✓. Left ventricular ejection fraction (LVEF) ≥ 50%.
Exclusion criteria
✕. Received anthracyclines, vinblastines, 6-mercaptopurine, 6-thioguanine, methotrexate, cytarabine, asparaginase, etc. within 7 days before infusion;
✕
What they're measuring
1
The number and severity of dose-limiting toxicity (DLT)events
Timeframe: Within 28 days after cell infusion
2
Frequency, type and severity of AES
Timeframe: Within 12 months after cell infusion
Trial details
NCT IDNCT07470073
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology