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Monoclonal Antibodies

1A46 Injection for Non-Hodgkin's Lymphoma and Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Research Sponsored by Chimagen Biosciences, Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aggressive NHL Patients with specified histologies and treatment history

Indolent NHL Patients with specified histologies and treatment history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to end of study or discontinuation due to disease progression, up to 5 years

Awards & highlights

Study Summary

This trial will test a new medication for people with B-cell non-Hodgkin's lymphoma or acute lymphoblastic leukemia.

Who is the study for?

Adults with advanced B-cell non-Hodgkin's lymphoma or acute lymphoblastic leukemia that have tried at least two other treatments and can't undergo or haven't benefited from stem cell transplant. They must not be using high-dose steroids, have active hepatitis, recent heart issues, major surgery, uncontrolled diseases, severe allergies to monoclonal antibodies, COVID-19 infection, another cancer within the last 5 years (with some exceptions), certain heart conditions or neurological issues.Check my eligibility

What is being tested?

The trial is testing a new injection called 1A46 for its safety and effectiveness in treating adults with specific types of blood cancers that express CD20 and/or CD19 proteins. The study will include patients who have already undergone multiple previous therapies without success.See study design

What are the potential side effects?

While the exact side effects are not listed here as it's a first-in-human trial of 1A46, common side effects for similar treatments may include allergic reactions to the drug components, potential immune system activation leading to inflammation in various organs (immune-related adverse events), fatigue and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a specific type of aggressive non-Hodgkin lymphoma and a certain treatment history.

Select...

I have a slow-growing type of non-Hodgkin lymphoma and a specific treatment history.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to end of study or discontinuation due to disease progression, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to end of study or discontinuation due to disease progression, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to end of study or discontinuation due to disease progression, up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Escalation: Dose liming toxicity (DLT)

Escalation: Incidence of Adverse Events

Secondary outcome measures

Escalation: Anti-drug antibody (ADA)

Escalation: Area Under the Concentration-Time Curve (AUC) from Time 0 to t

Escalation: Area under the serum concentration-time curve from time 0 to infinity (AUCinf)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

Open label, single arm trial where 1A46 will be administered

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Chimagen Biosciences, LtdLead Sponsor

Clinical Trial ManagementStudy DirectorChimagen Biosciences, Ltd

262 Previous Clinical Trials

251,109 Total Patients Enrolled

Media Library

1A46 Injection (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05348889 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Dose Escalation

Non-Hodgkin's Lymphoma Clinical Trial 2023: 1A46 Injection Highlights & Side Effects. Trial Name: NCT05348889 — Phase 1 & 2

1A46 Injection (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348889 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this research endeavor attempting to fulfill?

"This trial's primary objective is to evaluate Dose Limiting Toxicity (DLT) over the first 28 days of each participant cohort. Secondary objectives include measuring Time to Reach Cmax, Anti-Drug Antibody levels, and Total Clearance after intravenous administration - all which are used to assess the pharmacokinetic properties of 1A46."

Answered by AI

What is the upper limit in terms of participant numbers for this medical experiment?

"Affirmative. Clinicaltrials.gov evidences that this medical trial, which had its inception on August 30th 2022, is actively enrolling patients at two sites with a total of 165 participants required."

Answered by AI

Is enrollment for this experiment still open?

"Correct. According to clinicaltrials.gov, this study is actively searching for participants which were first posted on August 30th 2022 and most recently edited on September 26th of the same year. 165 patients need to be recruited from 2 distinct medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "First-in-Human (FIH) Trial of 1A46 in Subjects With Advanced CD20 and/or CD19 Positive B-cell Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05348889.