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CAR T-cell Therapy
Mana 312 for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Led By Lou Vaickus, MD
Research Sponsored by Mana Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Select
Subject has a donor who has agreed to donate leukocytes for manufacture of Mana 312 and who is the same donor who provided cells for the subject's current HSCT.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective in treating people with AML or MDS after a stem cell transplant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Escalation Cohorts: Identify the Maximum Tolerated Dose (MTD) of Mana 312 based on the safety and tolerability of single and multiple doses.
Escalation Cohorts: Identify the Recommended Phase 2 Dose (RP2D) of Mana 312 based on the safety and tolerability of single and multiple doses.
Expansion Cohort: Assess preliminary antitumor efficacy of Mana 312 by CR.
+1 moreSecondary outcome measures
Escalation Cohorts: Assess preliminary evidence of Mana 312 antitumor efficacy by CR.
Escalation Cohorts: Assess preliminary evidence of Mana 312 antitumor efficacy by PFS.
Expansion Cohort: Confirm safety of the RP2D by measurement of TEAEs.
Other outcome measures
Assess potential cytokine induction pharmacodynamic markers of Mana 312
Characterize the anti-drug antibody (ADA) response to Mana 312.
Characterize the pharmacokinetics (PK) by measurement of Mana 312 cell counts
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Mana 312Experimental Treatment1 Intervention
Mana 312 is administered intravenously (IV) within 30 minutes in either an inpatient or outpatient setting; either a central or peripheral IV line may be used. Each cycle of administration of Mana 312 will be 28 days.
Subjects not experiencing dose-limiting toxicity (DLT) following their initial dose may continue receiving their assigned Mana 312 dose every 28 days for an additional 2 doses
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Who is running the clinical trial?
Mana TherapeuticsLead Sponsor
Lou Vaickus, MDPrincipal InvestigatorMana Therapeutics Interim Chief Medical Officer
1 Previous Clinical Trials
116 Total Patients Enrolled
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