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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
Male or female aged ≥ 18 years at the time of signing the informed consent
Having the HA1+/- or HA-1+/+ (HA-1 positive) genotype to be eligible for TSC-100 treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years or older.
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I have the HA-1 positive genotype.
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My organs are healthy enough for a transplant according to hospital rules.
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I can take care of myself and perform daily activities.
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I have a family member who matches me closely enough to be a stem cell donor.
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I have the HA-2 positive genotype.
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I am preparing for a stem cell transplant for my leukemia or MDS.

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

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

Side effects data

From 2016 Phase 1 & 2 trial • 59 Patients • NCT01465347
100%
Alopecia
33%
Edema peripheral
33%
Neutropenia sepsis
33%
Tooth abscess
33%
Gait disturbance
33%
Injection site bruising
33%
Hypertension
33%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
TSC 0.25 mg/kg - 9 Dose Group
TSC 0.25 mg/kg - 18 Dose Group

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TScan Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
1,030 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-100 Treatment Arm, TSC 101 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues has this clinical trial been enacted in?

"5 trial sites are participating in this clinical study, including the Karmanos Cancer Institute located in Detroit, City of Hope based in Duarte and Hackensack University Medical Center from Hackensack. Additionally, there are a couple other medical centres included as well."

Answered by AI

What aims is this scientific experiment looking to accomplish?

"The primary endpoint of this two-year investigation is to determine the occurrence rate of adverse reactions caused by a high dosage. Secondary objectives include determining disease-free survival in patients compared with that of the control group at 18 months, contrasting relapse rates between participants and those within the comparative arm at 12 months, as well as examining disease-free survival among patients and controls after 24 months have elapsed. Participants alive without evidence of their condition will be censored during final follow up."

Answered by AI

What potential health hazards might accompany the use of SOC + TSC-101?

"Assessed on a scale from 1-3, our team at Power deemed the safety of SOC + TSC-101 to be a 1 due to its Phase 1 status which implies that there is only preliminary evidence for both efficacy and security."

Answered by AI

What is the capacity of the clinical trial with regards to participants?

"Affirmative. The data hosted on clinicaltrials.gov says this medical experiment, initially made available to the public on November 1st 2022 is currently looking for participants. Altogether 63 individuals need to be registered from 5 different hospitals."

Answered by AI

Is there availability for individuals to join this experiment?

"As per the details on clinicaltrials.gov, this investigation is currently recruiting participants. The trial was made public on November 1st 2022 and received its latest update on November 15th 2022."

Answered by AI
~20 spots leftby Dec 2024