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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)
ClinicalTrials.gov ID: NCT05667506
What this study is testing
What is single dose of CNCT19?
single dose of CNCT19 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian)
- Age 3 to 18. Weight ≥10kg
- Relapsed or refractory acute lymphoblastic leukemia (ALL).
- Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
You likely can't join if
- Active Central Nervous System (CNS) involvement by malignancy.
- Isolated extra-medullary disease relapse.
- Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis
- History of concomitant genetic syndrome
- Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.
- Active systemic autoimmune disease
See the full eligibility criteria
- Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian)
- Age 3 to 18. Weight ≥10kg
- Relapsed or refractory acute lymphoblastic leukemia (ALL).
- Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
- Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age \< 16 years) performance status ≥ 50 at screening
- Organ function requirements: All patients must have adequate renal and liver functions Key
- Active Central Nervous System (CNS) involvement by malignancy.
- Isolated extra-medullary disease relapse.
- Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis
- History of concomitant genetic syndrome
- Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.
- Active systemic autoimmune disease
- Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive).
- Patients with active infections at screening.
- Patients who received specified chemotherapy before CNCT19 infusion
- 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.
- Donor lymphocyte infusion (DLI) must be stopped \> 6 week prior to CNCT19 infusion.
- Has had treatment with any prior CAR-T therapy.
- Life expectancy \< 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China; Xuzhou, Jiangsu, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.