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Allogeneic T Cell Therapy for Blood Cancers

Phase 1 & 2
Recruiting
Led By Jaap-Jan BOELENS, MD, PhD
Research Sponsored by Smart Immune SAS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 24 post-hsct
Awards & highlights

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.

Who is the study for?
This trial is for children and adults with blood cancers who need a stem cell transplant but don't have a perfect donor match. They should be in at least their second complete remission or have low levels of remaining cancer cells. Participants must be fit enough for the transplant, with good organ function and performance status.Check my eligibility
What is being tested?
The study tests SMART101 injections to speed up immune recovery after a T-cell depleted stem cell transplant in patients with blood cancers. It aims to determine how safe and effective these cultured human T lymphoid progenitors are post-transplant.See study design
What are the potential side effects?
While specific side effects aren't listed, potential risks may include reactions at the injection site, immune system complications, or issues related to rapid immune reconstitution following transplantation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 24 post-hsct
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 post-hsct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CD4+ T cell count
Cumulative incidence of grade III-IV GvHD
Occurrence of adverse events related to SMART101
Secondary outcome measures
Communicable Diseases
Non-relapse mortality (NRM)
T cell immune reconstitution
Other outcome measures
Disease-free Survival
Overall Survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pediatric patients affected by hematological malignanciesExperimental Treatment1 Intervention
Pediatric patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) eligible for a T depleted allogeneic HSCT
Group II: Adult patients affected by hematological malignanciesExperimental Treatment1 Intervention
Adult patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) or myelodysplastic syndrome eligible for a T depleted allogeneic HSCT

Find a Location

Who is running the clinical trial?

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

Media Library

Allogeneic T cell progenitors, cultured ex-vivo Clinical Trial Eligibility Overview. Trial Name: NCT04959903 — Phase 1 & 2
Blood Cancers Research Study Groups: Adult patients affected by hematological malignancies, Pediatric patients affected by hematological malignancies
Blood Cancers Clinical Trial 2023: Allogeneic T cell progenitors, cultured ex-vivo Highlights & Side Effects. Trial Name: NCT04959903 — Phase 1 & 2
Allogeneic T cell progenitors, cultured ex-vivo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04959903 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollments still open for this experiment?

"This medical research, which was initially published on December 1st 2021, is actively searching for participants. Recent updates to the study were made on December 9th 2021 according to clinicaltrials.gov."

Answered by AI

What is the population size currently enrolled in this research project?

"Confirmed. The study in question, which was initially posted on December 1st 2021, is currently recruiting patients. 36 participants need to be sourced from a single healthcare facility."

Answered by AI
~14 spots leftby Aug 2025