TerminatedPhase 1/2

First-in-Human (FIH) Trial of 1A46 in Subjects with Advanced CD20 And/or CD19 Positive B-cell Hematologic Malignancies

Stopped: Sponsor's Research and Development strategy adjustment

United States7 participantsStarted 2022-08-30

Plain-language summary

This study will evaluate the safety and efficacy of 1A46 in adult patients with advanced CD20 and/or CD19 positive B-cell non-Hodgkin's lymphoma (NHL) or acute lymphoblastic leukemia (ALL).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Preinduction salvage chemotherapy and ASCT should be considered 1 therapy.
✓. Patients with gastric extranodal MZL, should have failed H. pylori eradication therapy (when H. pylori positive).

Exclusion criteria

✕. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroids.
✕. Dexamethasone used to reduce peripheral blast counts in ALL patients.

What they're measuring

Escalation: Incidence of Adverse Events

Timeframe: Adverse Events are assessed during the first cycle (28 days) in each cohort

Escalation: Dose liming toxicity (DLT)

Timeframe: DLTs are assessed during the first cycle (28 days) in each cohort

Trial details

NCT IDNCT05348889

SponsorChimagen Biosciences, Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Non-Hodgkin's Lymphoma (disorder) trials