Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide

Smart Immune

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hematological Malignancies

Treatments: Biological: Allogeneic T cell progenitors, cultured ex-vivo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05768035

SI101-02

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a haploidentical donor with post-transplant cyclophosphamide.
• Patients must be ≥ 18 years of age at the time of signing the ICF.
• Patients must have a Karnofsky index ≥ 70%.
• Patients must have a left ventricular ejection fraction of ≥40%.
• Patients must have an intact pulmonary function or Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) ≥ 45% of predicted.
• Patients must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.

Main Exclusion Criteria:

• Patients who have received prior allogeneic stem cell transplantation.
• Patients who have received prior treatment with another cellular therapy within 4 weeks before the planned day of SMART101 infusion.
• Patients who plan to receive, are concurrently receiving or have received any investigational agent within 4 weeks before the planned day of SMART101 infusion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT

Experimental group

Description:

Segment 1: 3 dose-level SMART101 cells/infusion 1. 1.5 x 106 CD7+ cells per kg of body weight 2. 4.5 x 106 CD7+ cells per kg of body weight 3. 9.0 x 106 CD7+ cells per kg of body weight Segment 2: 2 cohorts of patients will be included in the study based on the type of conditioning regimen: * The cohort A will include up to 17 patients receiving a myeloablative conditioning (MAC). * The cohort B will include up to 17 patients receiving a reduced intensity conditioning (RIC). * Enrollment of patients in each cohort will be done in parallel.

Treatment:

Biological: Allogeneic T cell progenitors, cultured ex-vivo