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Experimental Drug for Leukemia Post-Stem Cell Transplant

Phase 1
Recruiting
Research Sponsored by TScan Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two different doses of an experimental drug to see if it is safe and effective in treating patients with leukemia who have received a stem cell transplant from a related donor.

Who is the study for?
Adults (≥18 years) with AML, ALL, or MDS preparing for haploidentical donor transplantation. They must have specific HLA types and genotypes (HA1+/- or HA-1+/+ for TSC-100; HA2+/- or HA-2+/+ for TSC-101), good organ function, and an ECOG performance status ≤ 2. Contraception is required during the study and up to a year after. Exclusions include unsuitability for cell therapy, certain heart conditions, hypersensitivity to murine proteins, high levels of donor-specific HLA antibodies without alternative donors.
What is being tested?
The trial tests two treatments: SOC + TSC-100 and SOC + TSC-101 against a control group in patients undergoing stem cell transplantation from a half-matched donor. It's open-label with multiple arms assessing safety, feasibility, and preliminary effectiveness of escalating doses of these therapies.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with stem cell transplants such as infection risk due to immune suppression, reactions related to infusion of new cells (like fever or chills), graft-versus-host disease where the donated cells attack the body's tissues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Occurrence of adverse events
Occurrence of dose limiting toxicities
Secondary study objectives
Anti TSC-100 antibodies
Anti TSC-101 antibodies
Comparison of disease free survival in patients versus the control arm
+3 more
Other study objectives
Analysis of MRD
Analysis of donor chimerism
HA-1 persistence
+1 more

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: TSC-100 Treatment ArmExperimental Treatment1 Intervention
HA-1 positive patients
Group II: TSC 101 Treatment ArmExperimental Treatment1 Intervention
HA-1 negative and HA-2 positive patients
Group III: Standard of Care or Control armActive Control1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TScan Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
1,330 Total Patients Enrolled
Shrikanta Chattopadhyay, MDStudy DirectorTscan Therapeutics

Media Library

Control (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05473910 — Phase 1
Acute Myeloid Leukemia Research Study Groups: TSC 101 Treatment Arm, TSC-100 Treatment Arm, Standard of Care or Control arm
Acute Myeloid Leukemia Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT05473910 — Phase 1
Control (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05473910 — Phase 1
~0 spots leftby Dec 2024
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