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OncoMatch/Clinical Trials/NCT04959903

Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT

Is NCT04959903 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Allogeneic T cell progenitors, cultured ex-vivo for hematological malignancies.

Phase 1/2RecruitingSmart Immune SASNCT04959903Data as of May 2026

Treatment: Allogeneic T cell progenitors, cultured ex-vivoThe purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with hematological malignancies.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Biomarker criteria

Allowed: TP53 any mutation

mutations of TP53

Prior therapy

Must have received: T cell depleted allogeneic hematopoietic stem cell transplantation

Patient eligible for a T-depleted allogeneic HSCT

Cannot have received: allogeneic stem cell transplantation

Prior therapy with allogeneic stem cell transplantation

Cannot have received: cellular therapy

Exception: within one month before inclusion

Treatment with another cellular therapy within one month before inclusion

Lab requirements

Blood counts

normal organ function prior to conditioning regimen

Kidney function

normal organ function prior to conditioning regimen

Liver function

normal organ function prior to conditioning regimen

Cardiac function

normal organ function prior to conditioning regimen

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Memorial Sloan Kettering Cancer Center (MSKCC) · New York, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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