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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: hehuangyu@126.com
• Phone: 0571-87233772

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL

  This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07927816

• Umbilical Cord Blood CAR-T Cells Targeting CD19 and CD22 for relapsed/refractory B-ALL

  This phase 1 study tests whether dual-target cord blood-derived CAR-T cells against CD19 and CD22 are safe and tolerable in adults with relapsed or refractory B-cell ALL.

  Recruiting Phase 1 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07838714

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Dual-target CD22/CD19 CAR-T consolidation after first remission in high-risk B-ALL

  This test will try a dual-target CD22/CD19 CAR-T cell treatment as consolidation for patients with high-risk B-cell acute lymphoblastic leukemia who are in their first remission.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07575971

• CD22/CD19 CAR-T consolidation for adults with standard-risk B-ALL

  This study will try dual-target CD22/CD19 CAR-T cell therapy as a consolidation treatment for adults with standard-risk B-cell acute lymphoblastic leukemia who are in first remission.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07575919

• Fludarabine dosing for children and young adults with B-cell acute lymphoblastic leukemia

  This trial will test whether pharmacokinetic (PK)-targeted fludarabine dosing before tisagenlecleucel CAR T-cell therapy helps children and young adults with relapsed or refractory B‑cell ALL more than standard fludarabine dosing.

  Recruiting at 7 sites Phase 3 Memorial Sloan Kettering Cancer Center · New York, New York and 7 other locations · NCT07223021

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.