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This trial will test a new medication for people with B-cell non-Hodgkin's lymphoma or acute lymphoblastic leukemia.
- Non-Hodgkin's Lymphoma
- Acute Lymphoblastic Leukemia
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
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Who is running the clinical trial?
- 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.
- Group 1: Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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