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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05768035
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Smart Immune SAS
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Fabio CICERI, MD, Pr.
Principal Investigator Affiliation I.R.C.C.S. Ospedale San Raffaele
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hematological Malignancies
Arms & Interventions

Arms

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

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.

Interventions

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

Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Institut Paoli Calmettes, Marseille 2995469, France

Status

Recruiting

Address

Institut Paoli Calmettes

Marseille 2995469, , 13009

Nantes 2990969, France

Status

Recruiting

Address

Centre hospitalier universitaire de Nantes

Nantes 2990969, , 44093

Hôpital Saint-Louis, Paris 2988507, France

Status

Recruiting

Address

Hôpital Saint-Louis

Paris 2988507, , 75010

Toulouse 2972315, France

Status

Recruiting

Address

CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole

Toulouse 2972315, , 31059

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