TCR Engineered Donor T-Cells

A Controlled Multi-Arm Ph1 Study Evaluating the Safety and Feasibility of TCR Engineered Donor TCells Targeting HA1 (TSC-100) or HA2 (TSC-101) in HLA-A0201 Positive Patients Undergoing Haploidentical Allogeneic Stem Cell Transplantation

What's the purpose of the trial?

This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
63
Last Updated
2 months ago
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Participating Centers

There are 11 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

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  • TSC-100 is a T cell therapy made from genetically engineered donor T cells. This therapy is being studied for use in patients who have recently had a haploidentical stem cell transplant.
  • TSC-101 is a T cell therapy made from genetically engineered donor T cells. This therapy is being studied for use in patients who have recently had a haploidentical stem cell transplant.

Arms / Cohorts

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Accepting patients

TSC-100 Treatment Arm

Accepting patients

TSC 101 Treatment Arm

Accepting patients

Standard of Care

Published Results

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TScan Therapeutics Presents Promising Updated Phase 1 Clinical Results on TSC-100 and TSC-101 at the 2024 Tandem Meetings of ASTCT and CIBMTR

TSC-100 treatment arm (N=4: T-ALL, AML, AML, MDS)

  • 4/4 patients treated with TSC-100 achieved complete donor chimerism with no relapse.

TSC-101 treatment arm (N=4: TP53-mutated MDS, AML, B-ALL, B-ALL)

  • 4/4 patients treated with TSC-101 achieved complete donor chimerism with no relapse, including a patient with high-risk, TP53-mutated MDS who has reached one year of follow-up.
  • One patient with AML was MRD-positive following HCT and converted to and maintained MRD-negative status following treatment with TSC-101 (most recent measurement at day 180).

TSC-100 and TSC-101 persistence noted for prolonged periods:

  • Persistence of TSC-100 and TSC-101 was observed at all time points after dosing, with the longest follow-up of over 9 months.
  • Repeat dosing (dose levels 2 and 3) led to a 3-fold increase in circulating TSC-100 and TSC-101 levels compared to single dosing (dose level 1) at the same time points.

Six control arm patients (MDS, MDS, MDS, AML, AML, AML) have been enrolled and received standard of care HCT alone:

  • One control-arm patient with high-risk, TP53-mutated MDS evolved with MRD positivity and worsening mixed chimerism, experienced clinical relapse approximately six months post-transplant, and succumbed to relapse approximately nine months post-transplant.
  • One control-arm patient with MDS experienced clinical relapse approximately five months post-transplant.
  • One control-arm patient with MDS developed worsening mixed chimerism requiring early termination of immunosuppression, resulting in complete donor chimerism but with grade 1 skin graft-versus-host disease.
  • One control-arm patient never achieved complete donor chimerism, with more than four months follow-up post-transplant.
  • 2/6 control-arm patients achieved complete donor chimerism following HCT.
8 months ago Read more

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