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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aggressive NHL Patients: Aggressive NHL including mantle cell lymphoma and DLBCL histologies, NOS and/or BCL2, BCL6, and or MY B-cell lymphoma with intermediate features between DLBCL, FL grade 3B, and aggressive B-cell lymphoma unclassifiable have previously R-CHOP, R-EPOCH or equivalent anti-CD20 containing therapy with ≥ 2 prior lines of systemic therapy received or ineligible for autologous stem cell transplant (ASCT) have received or been intolerant of all other standard therapies thought to confer clinical benefit.
Indolent NHL Patients: including FL of Grades 1-3A and marginal zone lymphoma (MZL) refractory or relapsed after ≥ 2 prior lines of systemic therapy who have received or been intolerant of all other standard therapies thought to confer clinical benefit. Patients must require systemic therapy based on disease-specific criteria.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom baseline up to end of study or discontinuation due to disease progression, up to 5 years
Awards & highlights
No Placebo-Only Group
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 belowSelect...
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.
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
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 moreAwards & 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- For NHL patients:
- You have previously received specific treatments for NHL.
- You have measurable target lesions as defined by Lugano 2014 criteria.
- Your cancer cells express CD20 and/or CD19.
- If you have gastric extranodal MZL, you have failed H. pylori eradication therapy (when H. pylori positive).
For ALL patients:
- You have Ph-positive or Ph-negative B-cell ALL that has not responded to frontline treatment and at least one salvage regimen.
- You cannot receive or have already received all standard therapies thought to be effective.
- You cannot receive or have already received an allogeneic SCT.
- You do not have active acute or chronic graft-versus-host disease for 2 months prior to enrollment and currently receiving no immunosuppressive therapy.
- Your cancer cells have persistent CD19 staining of ≥ 50% of blasts.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.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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