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Donor T-cell infusions, TSC-100 and TSC-101, after a half-matched (haploidentical) blood or marrow transplant (BMT) to treat acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS)

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18 and older

Phase 1

15 Locations

NCT05473910

Clinical Trial Goal

To find out:
  • The highest dose of TSC-100 and TSC-101 that's safe to give after haploidentical BMT 
  • If TSC-100 and TSC-101 after a haploidentical BMT is safe and works well to treat ALL, AML or MDS

You may be able to join this trial if you:

  • Are 18 years old or older
  • Have ALL, AML or MDS
  • Have a family member who is your half match and can be your donor. Your biological parents and children are always a half-match for you.
  • Plan to have a haploidentical BMT 
  • Have not had an allogeneic (cells from a donor) BMT before
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details

TSC-100 and TSC-101 are T cells, a type of immune cell, from a donor that have been treated to target HA-1 and HA-2, respectively. 
 
Depending on your Human Leukocyte Antigen (HLA) type, you'll be put in 1 of 3 groups:
  • Group 1: TSC-100 
  • Group 2: TSC-101
  • Group 3: Standard care 

Before transplant, you’ll get standard reduced-intensity treatment to prepare your body to receive the donated blood-forming cells.

Then, on transplant day, the blood-forming cells from your donor are given to you through an intravenous (IV) infusion.

You'll also get standard treatment to prevent graft-versus-host disease (GVHD).

If you're in Group 1 or Group 2 you'll get:
  • TSC-100 – Group 1 only - Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • TSC-101 – Group 2 only - Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been

You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years.

The Food and Drug Administration (FDA) has not yet approved TSC-100 or TSC-101. The FDA has approved all of the other drugs used in this trial. 

Contacts

Jim Murray, 8573999500, medicalaffairs@tscan.com

Locations

City of HopeRECRUITING

Duarte, California
Monzr M Al Malki, MD

YaleRECRUITING

New Haven, Connecticut
Iris Isufi, MD

Memorial Healthcare SystemRECRUITING

Hollywood, Florida
Hugo Fernandez, MD

Northside HospitalRECRUITING

Atlanta, Georgia
Melholm Sohl, MD

John Hopkins UniversityRECRUITING

Baltimore, Maryland
Tania Jain, MD

Mass General HospitalRECRUITING

Boston, Massachusetts
Yi-Bin Chen, MD

Karmanos Cancer InstituteRECRUITING

Detroit, Michigan
Joseph Uberti, MD

Hackensack University Medical CenterRECRUITING

Hackensack, New Jersey
Hyung Suh, MD

Columbia UniversityRECRUITING

New York, New York
Ran Reshef, MD

Mount SinaiRECRUITING

New York, New York
Alla Keyzner, MD

University North CarolinaRECRUITING

Chapel Hill, North Carolina
Anson Snow, MD

UPennRECRUITING

Philadelphia, Pennsylvania
Saar Gill, MD

Baylor University Medical CenterRECRUITING

Dallas, Texas
Luis Pineiro, MD

MD AndersonRECRUITING

Houston, Texas
Uday Popat, MD

Froedert and Medical College of WisconsinRECRUITING

Milwaukee, Wisconsin
Sameem Abedin, MD

ClinicalTrials.gov record

NCT05473910. First posted on 7/26/22

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