A Study of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies
NCT04880564 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2022-10-24
Summary
The study is designed to investigate the safety, tolerability and preliminary efficacy in combination with CN1 and CN401 in adult patients with relapsed/refractory lymphoid malignancies.
Conditions
- Relapsed Lymphoid Malignancies
- Refractory Lymphoid Malignancies
Interventions
- DRUG
-
CN1, 0.5mg/kg and CN401, 400mg
CN1(0.5mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(400mg) will be administered orally twice daily.
- DRUG
-
CN1, 1mg/kg and CN401, 600mg
CN1(1mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(600mg) will be administered orally twice daily.
- DRUG
-
CN1, 1mg/kg and CN401, 800mg
CN1(1mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.
- DRUG
-
CN1, 3mg/kg and CN401, 800mg
CN1(3mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.
- DRUG
-
CN1, 10mg/kg and CN401, 800mg
CN1(10mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.
Sponsors & Collaborators
-
Novotech (Australia) Pty Limited
collaborator INDUSTRY -
Curon Biopharmaceutical (Australia) Co Pty Ltd
lead INDUSTRY
Principal Investigators
-
Jake Shortt · Monash Health
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-28
- Primary Completion
- 2022-08-29
- Completion
- 2022-09-30
Countries
- Australia
Study Locations
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