ThisCART19A Bridging to alloHSCT for R/R B-ALL

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Dec 27, 2022

Keywords

ClinConnect Summary

This clinical trial, called ThisCART19A, is studying a new treatment for adults with a type of blood cancer known as refractory or relapsed B-cell acute lymphoblastic leukemia (B-ALL). The goal is to see how well a special therapy called CAR-T cell therapy works in patients who have not responded to standard treatments. This trial is currently looking for participants aged 14 to 65 who are planning to receive a stem cell transplant (HSCT) and have been diagnosed with this type of leukemia.

To join the study, participants need to meet certain criteria, such as having a specific type of leukemia that has returned after treatment or did not respond to it. They should also be in generally good health, with a life expectancy of at least eight weeks. If you or someone you know is interested in this trial, they can expect to receive close monitoring and care throughout the study to ensure their safety. It's important to note that there are some conditions that would exclude someone from participating, such as having severe infections or certain other health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.
• • 2. No gender limitation, 14 years ≤ age ≤ 65 years.
• • 3. Intention to HSCT therapy.
• • 4. Meeting the diagnostic criteria of relapsed or refractory B-ALL. Relapsed B-ALL: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR. Refractory B-ALL: Failure to achieve CR or CRi at the end of induction therapy (General refers to a 4-week regimen or a Hyper-CVAD regimen); Subjects with Ph+ disease are eligible if they are intolerant to TKI therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs.
• • 5. Life expectancy ≥ 8 weeks at the time of enrollment.
• • 6. Eastern Cooperative Oncology Group performance status score of 0 or 1.
• 7. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function:
• • 1. Adequate marrow function for lymphodepletion chemotherapy assessed by the investigator.
• • 2. Creatinine clearance \> 30 mL/min according to the Cockcroft-Gault formula;
• • 3. ALT and AST ≤ 5 × ULN (the upper limit of normal), total bilirubin ≤ 2×ULN. (Subjects with Gilbert syndrome or liver involvement may be included if their total bilirubin is ≤ 3 × ULN.)
• • 4. Oxygen saturation (SaO2) ≥ 92% on room air.
• • 5. Cardiac function：left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography.
• • 8. CD19-positive leukemia obtained from bone marrow or peripheral blood confirmed by flowcytometry or biopsy during screening.
• Exclusion Criteria:
• • 1. Allergic to preconditioning measures.
• • 2. History of allogeneic HSCT.
• • 3. Other malignancies apart from B-cell malignancies within 5 years prior to screening. (Subjects with cured skin squamous carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be enrolled.)
• • 4. Severe active infection. (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted.)
• • 5. Pulmonary embolism within 3 months prior to enrollment.
• • 6. Severe cardiovascular and cerebrovascular diseases and hereditary diseases intolerant to CAR-T therapy assessed by the investigator prior to enrollment.
• • 7. Presence of symptomatic CNS involvement (both primary and secondary) at screening confirmed by imaging;
• • 8. Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects with HBV-DNA \< 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.)
• • 9. Vaccinated with influenza vaccine within 2 weeks prior to lymphodepletion chemotherapy. (Subjects vaccinated with SARS-COV19 vaccine or inactivated, live/non-live adjuvant vaccines can be enrolled.)
• • 10. Female subjects who are pregnant, breastfeeding or planning for pregnancy within 1 year after CAR-T cell infusion, or male subjects whose partners are planning for pregnancy within 1 year after CAR-T cell infusion.
• • 11. Any conditions that would, in the investigator's assessment, increase risks in patients or interfere with the outcomes of the trial.