Donor-derived CD19 CAR T cells with allo‑HSCT followed by donor-derived CD22 CAR T cells for relapsed/refractory B‑ALL

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 is a single-arm, open‑label phase I trial that gives donor-derived CD19 CAR T cells, then an allogeneic hematopoietic stem‑cell transplant (allo‑HSCT), and later donor-derived CD22 CAR T cells to patients with relapsed/refractory CD19+/CD22+ B‑ALL. The primary focus is safety, tolerability, and pharmacokinetics, with dose‑limiting toxicities monitored in the first 28 days after the CD19 CAR infusion and adverse events tracked through 120 days and up to two years. Eligible patients are aged 1–18 with high peripheral blood tumor burden or severe cytopenia preventing autologous lymphocyte collection and must have a DSA‑negative HLA‑identical or haploidentical donor. Secondary outcomes include preliminary measures of efficacy such as overall response rate.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing GoBroad Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Tengyu Wang
• Email: tengyu.wang@gohealtharo.com
• Phone: 86+18333186020

Similar studies

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

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• Comparing CD19 and CD22 CAR T-cell therapies for treating relapsed B-ALL

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

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

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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.