Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial

Launched by BEIJING GOBROAD HOSPITAL · Mar 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for children and young adults with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), a type of blood cancer. The trial aims to evaluate the safety and effectiveness of a two-step therapy involving special immune cells called CAR T-cells from a donor. The first step uses CD19 CAR T-cells, followed by a stem cell transplant, and then additional treatment with CD22 CAR T-cells. The researchers want to see how well patients tolerate the treatment and how effective it is in fighting their cancer.

To participate in this trial, patients must be between 1 and 18 years old and have a specific type of B-ALL that hasn't responded to standard treatments. They also need to have a suitable donor for the stem cell transplant. Participants can expect close monitoring for any side effects during the study and will be followed for up to two years to see how well the treatment works. It’s important for interested families to discuss this opportunity with their healthcare provider to understand all the details and whether it might be a good fit for their situation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Patients will be enrolled only if they meet all the inclusion criteria.
• • 1. Patients with relapsed or refractory CD19+/CD22+ (FCM \>95%) B-cell acute lymphoblastic leukaemia who have progressed despite or are intolerant to all standard therapies, including, but not limited to, immunotherapies such as Blinatumomab (BITE), Tyrosine kinase inhibitors (TKI), CAR T-cell therapy, etc.; Currently available therapies have a limited prognosis and there are no available curative treatment options (e.g., HSCT or chemotherapy);
• • 2. Peripheral blood tumour burden ≥60% or severe peripheral blood cytopenia, unsuitable/unable to collect autologous lymphocytes;
• • 3. 1 to 18 years old;
• • 4. Patient's expected survival time ≥ 60 days;
• • 5. Physical status: ECOG score 0-2;
• • 6. Availability of allogeneic donors (HLA-identical or HLA-haploidentical) DSA-negative for collection of peripheral blood mononuclear cells and peripheral blood stem cells;
• • 7. Sign an informed consent form during the screening period. Pediatric patients under 8\~18 years of age need to have sufficient awareness to voluntarily sign an informed consent form, and their legal representatives (guardians) also need to voluntarily sign an informed consent form; pediatric patients aged 1\~7 years can only be recruited after their legal guardians have voluntarily signed an informed consent form.
• Exclusion Criteria:
• • Patients who meet any of the following criteria are not eligible for enrolment.
• • 1. Patients who have received previous haematopoietic stem cell transplantation (including peripheral blood haematopoietic stem cell transplantation and bone marrow haematopoietic stem cell transplantation);
• • 2. Intracranial hypertension or cerebral impaired consciousness;
• • 3. Symptomatic heart failure or severe cardiac arrhythmia;
• • 4. Symptoms of severe respiratory failure;
• • 5. With other types of malignant tumours;
• • 6. Diffuse intravascular coagulation;
• • 7. Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
• • 8. Suffering from sepsis or other uncontrollable infections;
• • 9. Suffering from uncontrollable diabetes mellitus;
• • 10. Severe mental disorders;
• • 11. Have significant intracranial lesions on cranial MRI (excluding intracranial masses caused by central nervous system leukaemia);
• • 12. Have organ transplant history;
• • 13. Female patients (patients of childbearing potential) with positive blood HCG test;
• • 14. Hepatitis (including Hepatitis B and Hepatitis C) and positive screening for AIDS and syphilis;
• • 15. No allogeneic donor suitable for collection of peripheral blood lymphocytes and haematopoietic stem cells.