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GLIDE single infusion at a target dose of 4x107 viable T-cells/m2

Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line

GLIDE

Jean-Guy Némorin, PhD

Stéphanie Thiant, PhD

Denis-Claude Roy, MD PhD

Jean-Sébastien Delisle, MD PhD

Silvy Lachance, MD

This study will evaluate the safety of infusing an anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor.

The GLIDE-201/44 trial primarily aims to test the safety of anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor. The anti-MiHA T cell lines are derived from the matched donor for the patient, the original donor for a given patient. Both the patient and the matched donor will undergo screening to determine the expression of targetable MiHAs. Upon identification of the target MiHAs, donor cells will be collected through apheresis and primed against the selected MiHA. In this setting, the GLIDE 201/44 product will be cryopreserved, thawed and administered as a single infusion at a target dose of 4x10E+07 viable T cells/m2 (range of dose is 0.4 4x10E+07 viable T cells/m2). A second infusion can be offered to the patients after an observation period of 42 days upon clinical evaluation by the treating physician. In the absence of secondary adverse events following the initial infusion, a second infusion of the GLIDE 201/44 product could be administered at a dose level up to 3-5 fold the original dose.

Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)

An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Anti-minor Histocompatibility Complex (MiHA) Donor T-lymphocytes Expanded ex Vivo, in Patients With a Hematologic Malignancy, With Molecular or Clinical Relapse After Hematopoietic Stem Cell Transplantation From a Matched Donor

De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study end

No death or other toxic events directly related to GLIDE injection

Disease progression following GLIDE injection

Progression (if any) or induction of GvHD

Monitoring of GLIDE product persistence in host

Time to deaths without relapse/recurrence

It is time to any of the following: OS, RI, NRM, Time to relapse, Relapse free survival

Ciusss de L'Est de l'Île de Montréal

Leukemia, Myeloid

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Leukemia, Myelomonocytic, Acute

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Cytarabine

Decitabine

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Enzyme Inhibitors

FHD-286 administered orally + LDAC administered subcutaneously

FHD-286 administered orally + decitabine administered intravenously (IV)

FHD-286

Low Dose Cytarabine

Foghorn Clinical Trials

Brian Ball, MD

Richard Stone, MD

Eytan Stein, MD

Michael Savona, MD

Courtney DiNardo, MD

Sarah Reilly, MD

This Phase 1, multicenter, open-label, dose escalation study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects with advanced hematologic malignancies.

This study is primarily intended to evaluate the safety and tolerability of FHD-286 when administered orally as monotherapy or in combination with either LDAC or decitabine to subjects with R/R AML, R/R MDS, and R/R CMML not in blast crisis. In each arm of the study, successive cohorts of participants will receive increasing oral doses of FHD-286 as a single agent or in combination with LDAC or decitabine to determine the RP2D(s) in this population.

The data from this study in subjects with advanced hematologic malignancies, including safety, tolerability, PK/PD findings, and antitumor activity, will form the basis for subsequent clinical development of FHD-286.

FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies

A Phase 1, Multicenter, Open-Label, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286, as Monotherapy or Combination Therapy, in Subjects With Advanced Hematologic Malignancies

Foghorn Therapeutics Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)	NCT03091933	Hematologic Can... Relapse Leukemi... Relapsed Adult ... Relapsed Adult ... Relapsed CLL Relapsed Non Ho... Relapsed Hodgki... Relapsed Myelod... Relapsed Multip...	GLIDE	18 Years - 65 Years	Ciusss de L'Est de l'Île de Montréal
Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)	NCT03091933	Hematologic Can... Relapse Leukemi... Relapsed Adult ... Relapsed Adult ... Relapsed CLL Relapsed Non Ho... Relapsed Hodgki... Relapsed Myelod... Relapsed Multip...	GLIDE	18 Years - 65 Years	Ciusss de L'Est de l'Île de Montréal
FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies	NCT04891757	Advanced Hemato... Relapsed Acute ... Refractory Acut... Relapsed Myelod... Refractory Myel... Relapsed Chroni... Refractory Chro...	FHD-286 Low Dose Cytara... Decitabine	16 Years -	Foghorn Therapeutics Inc.

Spots Global Cancer Trial Database for relapsed myelodysplastic syndromes