Comparing CD19 and CD22 CAR T-cell therapies for treating relapsed 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 clinical trial evaluates the effectiveness of sequential infusions of CD19 and CD22 CAR T-cells compared to CD19 CAR T-cell infusion followed by hematopoietic stem cell transplantation (HSCT) in patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). It is a multi-center, open-label, non-randomized trial where patients can choose their treatment arm. The primary goal is to assess event-free survival in children and young adults receiving these therapies. A total of 353 subjects will be enrolled to provide robust data on treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Only patients who meet all the following criteria can be included in the group:

  1. Patients who were diagnosed as primary refractory or relapsed B-ALL. (Criterion-reference: NCCN, version 2.2023); All the patients matched the diagnostic criteria of ALL according to the NCCN guideline (≥20% bone marrow lymphoblasts on hematopathology review of bone marrow aspirate and biopsy materials, which were confirmed by comprehensive flow cytometric immunophenotyping, minimal residual disease analysis and karyotyping of G-banded metaphase chromosomes). Molecular characterization could be obtained via interphase fluorescence in situ hybridization (FISH) testing, reverse transcriptase polymerase chain reaction (RT-PCR) testing, comprehensive testing by next-generation sequencing (NGS) for gene fusions and pathogenic mutations, etc. Determination of the World Health Organization ALL subtypes and cytogenetic and clinical risk groups were also allowed. B-ALL patients who did not achieve a complete remission after previous therapy (including the various treatment response scenarios shown in Table 1), who did not achieve a complete remission after at least two lines of TKI agents (including the various treatment response scenarios shown in Table 1), or who had ≥1 relapses were defined as having refractory or relapsed disease. Patients who were diagnosed as CD19- and CD22-positive high-risk B-ALL with continuous positive minimal residual disease (MRD) for more than three months after last therapy were also eligible. Patients had positive CD19 and CD22 expression on leukemia blasts by FCM (\>80% CD19 and CD22 positive);
  2. Age from 1 to 70 years old;
  3. No serious allergic constitution;
  4. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;
  5. Have life expectancy of at least 60 days based on investigator's judgement;
  6. Voluntary informed consent is signed by self-aware patients aged 8-70 years and by legal representatives (guardians) of pediatric patients under 18 years of age.

Exclusion Criteria:

* Patients with at least one of the following conditions are excluded:

  1. Intracranial hypertension or unconscious;
  2. Acute heart failure or severe arrhythmia;
  3. Acute respiratory failure;
  4. Other types of malignant tumors;
  5. Diffuse intravascular coagulation;
  6. Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value;
  7. Sepsis or other uncontrolled infection;
  8. Uncontrolled diabetes mellitus;
  9. Severe psychological disorder;
  10. Obvious cranial lesions by cranial MRI;
  11. More than 20 leukemic cells/μL in cerebrospinal fluid;
  12. More than 30% leukemic cells in the peripheral blood;
  13. Organ recipients;
  14. Pregnant or breastfeeding;
  15. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).

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.

• CIK cell therapy for relapsed or refractory B‑cell acute lymphoblastic leukemia with early CAR‑T dysfunction

  We are testing whether giving regular or mRNA‑modified CIK cells helps children and young adults with relapsed or refractory B‑cell ALL who show early CAR‑T cell exhaustion stay free of relapse or disease progression longer.

  Recruiting Beijing GoBroad Hospital · Beijing, Beijing Municipality · NCT06389305

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

  This study tests donor-derived CD19 CAR T cells followed by an allogeneic stem‑cell transplant and sequential donor-derived CD22 CAR T cells in children and adolescents (1–18 years) with relapsed or refractory CD19+/CD22+ B‑ALL who cannot provide their own cells.

  Recruiting Phase 1 Beijing GoBroad Hospital · Beijing, Beijing Municipality · NCT06326008

• 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

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  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

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.