Allogeneic T cell progenitors, cultured ex-vivo for Acute Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute LeukemiaAllogeneic T cell progenitors, cultured ex-vivo - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a new treatment can help people with relapsed or refractory leukemia by increasing the speed of immune system recovery after a stem cell transplant.

Eligible Conditions
  • Acute Leukemia

Treatment Effectiveness

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Month 24 post-HSCT

100 days post-HSCT
CD4+ T cell count
Cumulative incidence of grade III-IV GvHD
Occurrence of adverse events related to SMART101
Month 6
Communicable Diseases
Non-relapse mortality (NRM)
Month 24 post-HSCT
Disease-free Survival
Overall Survival (OS)
Month 12
T cell immune reconstitution

Trial Safety

Trial Design

2 Treatment Groups

Pediatric patients affected by acute leukemia (AML, ALL)
1 of 2
Adult patients affected by acute leukemia (AML, ALL)
1 of 2

Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: Allogeneic T cell progenitors, cultured ex-vivo · No Placebo Group · Phase 1 & 2

Pediatric patients affected by acute leukemia (AML, ALL)
Biological
Experimental Group · 1 Intervention: Allogeneic T cell progenitors, cultured ex-vivo · Intervention Types: Biological
Adult patients affected by acute leukemia (AML, ALL)
Biological
Experimental Group · 1 Intervention: Allogeneic T cell progenitors, cultured ex-vivo · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 24 post-hsct

Who is running the clinical trial?

Smart Immune SASLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Jaap-Jan BOELENS, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center (MSKCC)

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
High risk in CR1; Philadelphia (like) or any poor risk feature.
You are eligible for an allogeneic HSCT.
You are aged 21 years or older and have a clinical condition compatible with allogeneic bone marrow transplantation.
You have a Karnofsky index of 70% or higher.