Treatment of relapsed or refractory B-cell leukemia in children and adolescents

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 multi-center, open-label, single-arm trial evaluating the safety and efficacy of CNCT19 in pediatric patients aged 3 to 18 years with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL). The trial consists of two phases: Phase Ib focuses on determining the optimal dose and assessing preliminary efficacy, while Phase II evaluates the overall efficacy and safety of the treatment. Participants will undergo screening, pre-treatment procedures, CNCT19 infusion, and follow-up for safety and survival for up to two years.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian)
2. Age 3 to 18. Weight ≥10kg
3. Relapsed or refractory acute lymphoblastic leukemia (ALL).
4. Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.
5. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
6. Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age \< 16 years) performance status ≥ 50 at screening
7. Organ function requirements: All patients must have adequate renal and liver functions

Key Exclusion Criteria:

1. Active Central Nervous System (CNS) involvement by malignancy.
2. Isolated extra-medullary disease relapse.
3. Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis
4. History of concomitant genetic syndrome
5. Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.
6. Active systemic autoimmune disease
7. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive).
8. Patients with active infections at screening.
9. Patients who received specified chemotherapy before CNCT19 infusion
10. Radiotherapy before CNCT19 infusion:

    Non-CNS site of radiation completed \< 4 weeks prior to CNCT19 Infusion; CNS directed radiation completed \< 8 weeks prior to CNCT19 infusion.
11. Donor lymphocyte infusion (DLI) must be stopped \> 6 week prior to CNCT19 infusion.
12. Has had treatment with any prior CAR-T therapy.
13. Life expectancy \< 3 months.

Where it's running

• Children's Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Recruiting
• Children's Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• The Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting
• The First Affilicated Hospital of Nanchang University
  Nanchang, Jiangxi, China Recruiting
• Institute of Hematology & Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Xiaofan Zhu, M.D — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Hui Ding
• Email: dinghui@juventas.cn
• Phone: +86-010-65960098

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

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• MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia

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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.