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

S

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)

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

Trial contacts and locations

4

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Central trial contact

Aurélie BAUQUET, PhD; Frédéric LEHMANN, MD

Data sourced from clinicaltrials.gov

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