Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05473910
Other study ID # TSCAN-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 1, 2022
Est. completion date June 2025

Study information

Verified date June 2024
Source TScan Therapeutics, Inc.
Contact Jim Murray
Phone 8573999500
Email jmurray@tscan.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SOC + TSC-100
HA-1 positive
SOC + TSC-101
HA-2 positive or HA-1 negative
Other:
Control
SOC alone

See more »

Sponsors (1)

Lead Sponsor Collaborator
TScan Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Analysis of donor chimerism Analysis of donor hematopoietic chimerism evaluated in bone marrow, whole unfractionated blood, or blood cell fractions, including CD3 and CD33 subsets. 60 days
Other Analysis of donor chimerism Analysis of donor hematopoietic chimerism evaluated in bone marrow, whole unfractionated blood, or blood cell fractions, including CD3 and CD33 subsets. 100 days
Other Analysis of MRD MRD status in bone marrow biopsies at Day 60 60 days
Other Analysis of MRD MRD status in bone marrow biopsies at Day 100 100 days
Other Analysis of MRD MRD status in bone marrow biopsies at Day 180. 180 days
Other HA-1 persistence Persistence of HA1 TCRT cells in the peripheral blood and bone marrow, measured in bone marrow or whole unfractionated blood by a central laboratory flow cytometric assay. 2 years
Other HA-2 persistence Persistence of HA2 TCRT cells in the peripheral blood and bone marrow, measured in bone marrow or whole unfractionated blood by a central laboratory flow cytometric assay. 2 years
Primary Occurrence of dose limiting toxicities Number of DLTs observed in patients compared to the control arm two years
Primary Occurrence of adverse events Number of adverse events in patients compared to control arm two years
Secondary Comparison of disease free survival in patients versus the control arm Disease-free survival in patients versus the control arm at 6 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up. 6 months
Secondary Comparison of disease free survival in patients versus the control arm Disease-free survival in patients versus the control arm at 12 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up. 12 months
Secondary Disease-free survival in patients versus the control arm at 18 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up. Disease-free survival at Month 18 defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up. 18 months
Secondary Comparison of disease free survival in patients versus the control arm Disease-free survival in patients versus the control arm at 24 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up. 24 months
Secondary Comparison of relapse rates between patients and control arm Relapse rates in patients versus the control arm at 6 months. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia or MDS consistent with pre-transplant features, or radiologic evidence of lymphoproliferative disorders, documented or not by biopsy. 6 months
Secondary Comparison of relapse rates between patients and control arm Relapse rates in patients versus the control arm at 12 months. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia or MDS consistent with pre-transplant features, or radiologic evidence of lymphoproliferative disorders, documented or not by biopsy. 12 months
Secondary Comparison of overall survival between patients and control arm Overall survival between patients versus the control arm, defined as the time interval between the date of transplant and death from any cause. Surviving participants will be censored at the last follow up. Up to 2 years
Secondary Anti TSC-100 antibodies Presence and concentration of anti TSC-100 antibodies. 2 years
Secondary Anti TSC-101 antibodies Presence and concentration of anti TSC-101 antibodies. 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Terminated NCT04313881 - Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) Phase 3
Recruiting NCT05088356 - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft Phase 1
Recruiting NCT04003220 - Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Active, not recruiting NCT03755414 - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation Phase 1
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT04866056 - Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF. Phase 1/Phase 2
Recruiting NCT04701229 - Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
Suspended NCT04485065 - Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS Phase 1
Recruiting NCT04174547 - An European Platform for Translational Research in Myelodysplastic Syndromes
Enrolling by invitation NCT04093570 - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers Phase 2
Completed NCT02508870 - A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes Phase 1
Completed NCT04543305 - A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies Phase 1
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Recruiting NCT05365035 - A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts Phase 2
Recruiting NCT06008405 - Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy Phase 1
Not yet recruiting NCT05969821 - Clonal Hematopoiesis of Immunological Significance
Withdrawn NCT05170828 - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies Phase 1