Treatment of relapsed or refractory B-cell leukemia in children and adolescents
A Phase Ib/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
This study is testing a new treatment called CNCT19 to see if it can help children and teenagers with relapsed or hard-to-treat B-cell leukemia feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Juventas Cell Therapy Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T, chemotherapy, radiation |
| Locations | 9 sites (Hefei, Anhui and 8 other locations) |
| Trial ID | NCT05667506 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 3 to 18 years with relapsed or refractory B-cell acute lymphoblastic leukemia who meet specific health criteria.
Not a fit: Patients with active central nervous system involvement by malignancy or those with certain types of leukemia or genetic syndromes may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children and adolescents suffering from a challenging form of leukemia.
How similar studies have performed: Other studies using CAR-T cell therapies for similar conditions have shown promising results, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hefei, Anhui and 8 other locations
- The Second Hospital of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
- Children's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (Recruiting)
- Nanfang Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Union Hospital Tongji Medical College Huazhong University of Science of Technology — Wuhan, Hubei, China (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.