Using donor-derived CAR-T cells to treat relapsed B-cell leukemia

A Clinical Study on the Safety and Effectiveness of Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

This study is testing a new type of CAR-T cell therapy made from donor cells to see if it can help people with relapsed B-cell leukemia feel better.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: CART, CAR-T, chemotherapy, prednisone
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06793241 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of donor-derived CD19 CAR-T cells in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). A total of 15 patients will receive the CAR-T cell therapy, which targets CD19 positive B cells. The study aims to gather more safety data and assess the treatment's effectiveness based on previous findings. Participants will be closely monitored for their response to the therapy and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory B-cell acute lymphoblastic leukemia who have not responded to standard treatments.

Not a fit: Patients who have not been adequately treated or those with other types of leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell acute lymphoblastic leukemia.

How similar studies have performed: Previous studies have shown promising results with CAR-T cell therapies for B-cell malignancies, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 1\. Age ≥18 years old, gender unlimited;
* 2\. Abnormal B cell immunotyping was CD19 positive;
* 3\. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping;
* 4\. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions:

  1. No CR was obtained after standard chemotherapy;
  2. CR was induced for the first time, but the duration of CR was less than 12 months;
  3. R/R B-ALL that does not work after the first or more remedial treatments;
  4. Two or more relapses;
* 5\. The researchers believed that the patient had been adequately treated, such as auto-HSCT, auto-CART could not be prepared or preparation failed. Autologous CAR-T preparation failure was defined as including too few autologous lymphocytes (\<1×109) or insufficient expansion during preparation or failure to meet the release criteria;
* 6\. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L);
* 7\. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin ≧60g/L;
* 8\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%;
* 9\. The estimated survival is more than 3 months;
* 10\. ECOG score 0-2;
* 11\. Women and men who are fertile must consent to the use of appropriate contraception before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known, with unknown risks);
* 12\. Subjects who are willing to participate in the study are able to understand and have the ability to sign informed consent.

Exclusion Criteria:

* 1\. Known allergies to research preconditioning measures, etc;
* 2\. People with a history of epilepsy or other central nervous system disorders;
* 3\. People with a history of prolonged QT or severe heart disease;
* 4\. Less than 100 days after receiving allogeneic hematopoietic stem cell transplantation;
* 5\. Hiv-infected person;
* 6\. Persons with active hepatitis B or C virus; Those who are not cured have active infections;
* 7\. Insufficient amplification ability (\< 5x) in response to CD3 / CD28 costimulatory signals;
* 8\. Combined use of systemic steroids (e.g., prednisone ≥20mg) within 3 days prior to screening, except for ongoing or intermittent use of topical, inhaled or intranasal steroids within 2 weeks or at present; Or have systemic diseases that require long-term use of immunological agents;
* 9\. Patients who received anti-cancer chemotherapy or other drugs within 2 weeks prior to screening;
* 10\. Any situation that the investigator believes may increase the risk of the subjects or interfere with the study results.

Where this trial is running

Hangzhou, Zhejiang

• The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: He Huang, MD — Zhejiang University
• Study coordinator: He Huang, MD

Conditions B-cell Acute Lymphoblastic Leukemia; CD19 CAR-T