CAR-T cell therapy for children with MRD-positive 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 safety and efficacy of CD19/CD22 dual-target CAR-T cell therapy in children with minimal residual disease (MRD) positive B-lineage acute lymphoblastic leukemia (B-ALL) after induction remission. The study involves preparing autologous CAR-T cells, administering them after lymphocyte depletion, and continuing chemotherapy post-infusion. The trial aims to improve outcomes for children who have not achieved complete remission after initial treatment. It is conducted at a single center in Guangzhou, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Parents or legal guardians fully understand, are informed of this study and sign the informed consent form (ICF); are willing to follow and can complete all test procedures.
2. Chinese children aged 1-18 years old at the time of screening, regardless of gender, with a body weight ≥ 10 kg.
3. Bone marrow examination confirms that MRD is still positive on the 46th day after induction remission.
4. Tumor cells in the bone marrow (BM) or peripheral blood (PB) express CD19/CD22 within 3 months before screening.
5. Good organ function, which needs to meet the following criteria: (1)ALT ≤ 5 times the upper limit of normal value (ULN); (2)total bilirubin ≤ 2 times ULN (Gilbert's syndrome ≤ 3 times ULN); (3)without \> grade 1 dyspnea when not inhaling oxygen, and oxygen saturation \> 95%; (4)left ventricular ejection fraction (LVEF) ≥ 50%; (5)serum creatinine ≤ 1.5 times ULN.
6. Karnofsky score (≥ 16 years old) ≥ 70 or Lansky (\< 16 years old) score ≥ 50.
7. Expected survival period of at least 12 weeks.
8. Have sufficient venous access (for apheresis or venous blood sampling), and have no other contraindications for blood cell separation.

Exclusion Criteria:

1. Have genetic diseases, except Down syndrome.
2. Have a history of other malignancies or have other malignancies simultaneously.
3. Meet any of the following conditions: (1)hepatitis B surface antigen (HBsAg) positive or HBV DNA quantification higher than the upper limit of normal value; (2)hepatitis C antibody (HCV Ab) positive and HCV RNA quantification higher than the upper limit of normal value; (3)human immunodeficiency virus antibody (HIV-Ab) positive; (4)Treponema pallidum antibody (TP-Ab) positive; (5)EBV DNA higher than the upper limit of normal value; (6)cytomegalovirus DNA higher than the upper limit of normal value.
4. Have or are suspected to have uncontrolled or require intravenous drug treatment for fungal, bacterial, viral or other infections.
5. Long-acting G-CSF is prohibited within 21 days before screening, and short-acting G-CSF is prohibited within 7 days before screening.
6. Have active central nervous system leukemia.
7. Are allergic to albumin and aminoglycoside antibiotics.
8. Have undergone organ transplantation (except hematopoietic stem cell transplantation).
9. Have participated in other interventional clinical studies within 3 months before screening (received active test drug treatment), or intend to participate in another clinical trial or receive anti-tumor treatment other than that specified in the protocol during the entire study period.
10. Cannot tolerate chemotherapy and cytokine storm due to impaired function of important organs.
11. Other situations that the investigator deems not suitable for participating in this clinical trial.

Where it's running

• Guangzhou Medical University Affiliated Women and Children's Medical Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hua Jiang, phd
• Email: jiang_hua18@sina.cn
• Phone: 86-020-38076051

Similar studies

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

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• At-home cognitive training and mindfulness for children after CAR-T, transplant, or chemotherapy

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• Using CD22 CAR T-cells to extend remission after commercial CD19 CAR T-cell therapy in children, adolescents, and adults with relapsed/refractory B‑ALL

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• CD19 CAR-T consolidation for adolescents and adults with B-ALL who cannot have a transplant

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• FIT-CD19 CAR-T (ARM011) therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia.

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• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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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.