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Monoclonal Antibodies

1A46 for B-cell Hematologic Malignancies

Yale New Haven Hospital, New Haven, CT
Targeting 2 different conditions1A46 InjectionPhase 1 & 2RecruitingResearch Sponsored by Chimagen Biosciences, Ltd

Study Summary

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

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Acute Lymphoblastic Leukemia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have a slow-growing type of lymphoma called indolent NHL, including FL of Grades 1-3A and marginal zone lymphoma (MZL). You have already tried at least two other treatments for your cancer that didn't work or caused intolerable side effects. Your doctor has determined that you need more treatment based on your specific type of cancer.


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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment1 Intervention
Open label, single arm trial where 1A46 will be administered

Find a Location

Who is running the clinical trial?

Chimagen Biosciences, LtdLead Sponsor
Clinical Trial ManagementStudy DirectorChimagen Biosciences, Ltd
247 Previous Clinical Trials
245,797 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
~66 spots leftby Oct 2024