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A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA)

StatusRecruiting
PhasePhase 1
Started2022-11-01
View on ClinicalTrials.gov ↗

Amendment history

2026-07-17
Study Identification, Study Status v18
Study title-7 characters
A Phase 1/3 Study of T-Cell Receptor Engineered Donor T Cells in Subjec [...] rgoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA)
2026-07-16
Study Identification, Study Status v17
Study title-4 characters
A Phase 1/3 Study of T-Cell Receptor Engineered Donor T Cells in Subjec [...] llogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)
2026-07-10
Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v16
Enrollment increased: 75 → 310 participants
Trial sites expanded: 15 → 21 locations
Completion pushed: 2026-06 → 2028-06
Primary completion dateestimated 2026-06→confirmed 2026-06-01
Eligibility criteria+2 characters
[...] g to undergo allogeneic HCT for either of the following: AML, MDS, ALL Participants in the treatment arms must express HLA-A*02 [...]
Study description+40 characters
[...] alan+/-total body irradiation, thiotepa+busulfan+fludarabine or, flurdarabine+melphalan+thiotepa or fludarabine+melphalan (for MMUds only). In addition, patients may receive other supportive care me [...]
Study title+27 characters
A Phase 1/3 Study of TSCT-100Cell andReceptor TSC-101Engineered Donor T Cells in AML, ALL and MDS in PatientsSubjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)
2026-04-02
Study Status, Eligibility v15
Primary completion date2025-12→2026-06
2025-05-14
Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Eligibility, Contacts/Locations v14
Enrollment target63→75
Eligibility criteria+227 characters
[...] be eligible for TSC-101 treatment. Having a haploidentical relateddonor, adultMMUD, donoror MUD for HCT who is adequately HLA-matched by institutional stan [...] nsidered to be clinically indicated for haploidentical donor, MMUD, or MUD transplantation at the discretion of the treating investiga [...] ke the participant an unsuitable candidate for cell therapy atincluding theanother discretionconcurrent ofuncontrolled themalignancy principalor investigatoractive (PI)CNS disease. The presence of organ toxicities will not necessarily excl [...] who have a history of hypersensitivity to murine proteins. Enrollment [...] [...]
Study description+5 characters
[...] y, safety, and preliminary efficacy of repeated dose regimen of up to 2 doses of TSC-100 and TSC-101 (TSC-100 and TSC-101 is a geneticall [...] h AML, MDS, or ALL following HCT from a haploidentical donor, MUD, or MMUD. The primary objective of this study is to investigate the [...] rradiation, fludarabine+melphalan+/-total body irradiation, or thiotepa+busulfan+fludarabine or flurdarabine+melphalan+thiotepa. In addition, patients may receive other supportive care measures and infectioousinfectious prophylaxis as necessary, according to institutional guidel [...] dose escalation design. Once the RP2D is identifi [...]
Study title+15 characters
A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing HaploidenticalAllogeneic DonorPeripheral Blood Stem Transplantation
Show 13 earlier versions
2025-01-22
Study Status, Oversight, Contacts/Locations v13
Primary completion date2024-12→2025-12
Completion date2025-06→2026-06
Study sites13→15
2024-06-12
Study Status, Conditions v12
Re-verified, no change to tracked fields
2024-05-29
Study Status, Contacts/Locations v11
Study sites11→13
2024-02-05
Study Status, Contacts/Locations v10
Study sites9→11
2023-12-06
Study Status, Contacts/Locations v9
Study sites7→9
2023-10-30
Study Status, Contacts/Locations v8
Start dateestimated 2022-11→confirmed 2022-11-01
Study sites5→7
2022-11-15
Study Status, Contacts/Locations v7
Study sites4→5
2022-11-02
Study Status, Contacts/Locations v6
Start date2022-10→2022-11
Study sitesdetails revised at 1 of 4 sites
2022-10-19
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 4 sites
2022-10-03
Study Status, Contacts/Locations v4
Start date2022-08→2022-10
Study sites2→4
2022-08-11
Study Status, Conditions, Contacts/Locations v3
Study sites1→2
2022-08-01
Study Identification, Study Status v2
Start date2022-07→2022-08
Study title+48 characters
A Study of TSC-100 and TSC-101 in AML, ALL and MDS Patients Undergoing Haploidentical Donor Transplantation
2022-07-27
Study Identification, Study Status, Outcome Measures v1
Secondary endpoints8 to 9 entries
SecondaryComparison of disease free survival in patients versus the control arm SecondaryComparison of disease free survival in patients versus the control arm SecondaryDisease-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. SecondaryComparison of disease free survival in patients versus the control arm SecondaryComparison of relapse rates between patients and control arm SecondaryComparison of relapse rat [...] [...]
Primary endpoints1 to 2 entries
PrimaryOccurrence of adverse events Occurrence of dose limiting toxicities
Study title-53 characters
A Study of TCRTSC-100 Engineeredand Donor T CellsTSC-101 in LeukemiaAML, ALL and MDS Patients Haploidentical Allogeneic Stem Cell Transplantation
2022-07-22
Original filing
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, MMUD, or MUD
Trial Details
NCT Number NCT05473910
Lead Sponsor TScan Therapeutics, Inc.
Conditions AML, MDS
Enrollment 310 participants
Start Date 2022-11-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-10-01