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Cell Therapy

T-allo10 for Blood Disorders (T-allo10 Trial)

Phase 1
Recruiting
Led By Rajni Agarwal, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Available mismatched related donor (mMRD) or mismatched unrelated donor (mMUD), Human leukocyte antigen (HLA) matched 8/10 or 9/10
Eligible diseases include Acute Lymphoblastic Leukemia (B- or T-ALL) with specific criteria for CR-1, CR-2, and CR-3, Acute Myeloid Leukemia with specific criteria, Myelodysplastic syndrome, Mixed Phenotype Acute Leukemia, Non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma (HL) beyond first remission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after day +100 through day +365,
Awards & highlights

T-allo10 Trial Summary

This trial is for a cell therapy, T-allo10, that would prevent GvHD in patients receiving mismatched related or unrelated donor HSCT for hematologic malignancies. This is the first trial of its kind in pediatric patients and is only available at Lucile Packard Children's Hospital, Stanford.

Who is the study for?
This trial is for patients aged 3 to 45 with certain blood disorders like various types of leukemia, lymphoma, and myelodysplastic syndrome who need a stem cell transplant but don't have a fully matched donor. They should be in good health otherwise, not pregnant or breastfeeding, willing to use birth control if applicable, and able to consent.Check my eligibility
What is being tested?
The trial tests T-allo10 cell therapy aiming to prevent graft-versus-host disease (GvHD) after receiving stem cells from a partially matched donor. It's the first of its kind for pediatric patients at Stanford and seeks to establish safety and tolerability.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with stem cell transplantation such as infection risk due to immune suppression, reaction at infusion site, organ inflammation related to GvHD prevention treatment.

T-allo10 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a donor who is an 8/10 or 9/10 match for my transplant.
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My condition is a type of blood cancer beyond the first remission.
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I am mostly active and can carry out daily activities without significant help.

T-allo10 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after day +100 through day +365,
This trial's timeline: 3 weeks for screening, Varies for treatment, and after day +100 through day +365, for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility defined by the successful manufacture of the T-allo10 product
Incidence of treatment emergent adverse events (TEAE)
T1220
+1 more
Secondary outcome measures
Incidence and severity of grade III and IV acute GvHD
Other outcome measures
Disease Free Survival
Incidence and severity of chronic GvHD
Time to immune reconstitution

T-allo10 Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Participants will receive 9 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant)
Group II: Cohort 2Experimental Treatment1 Intervention
Participants will receive 3 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant)
Group III: Cohort 1Experimental Treatment1 Intervention
Participants will receive 1 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant)

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,379 Previous Clinical Trials
17,333,363 Total Patients Enrolled
Roncarolo, Maria Grazia, MDLead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,317 Total Patients Enrolled

Media Library

T-allo10 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03198234 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Cohort 1, Cohort 2, Cohort 3
Acute Myeloid Leukemia Clinical Trial 2023: T-allo10 Highlights & Side Effects. Trial Name: NCT03198234 — Phase 1
T-allo10 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03198234 — Phase 1

Frequently Asked Questions

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

Is this research study enrolling elderly individuals?

"As per the requirements of this research project, children aged 3 and above but not exceeding 45 years old may take part."

Answered by AI

To what extent is the current clinical trial being populated?

"That is correct. According to clinicaltrials.gov, this research study has been actively recruiting since August 30th 2017 and was last updated on February 2nd 2022; it requires a total of thirty participants from one site."

Answered by AI

Are there still openings in this experiment for volunteers?

"This clinical trial is currently recruiting participants, as indicated on the clinicaltrials.gov website. This research was initially posted in August 2017 and has been updated most recently in February 2022."

Answered by AI

Has the United States Food and Drug Administration sanctioned T-allo10?

"Our experts at Power rate T-allo10's safety as a 1, which is customary for Phase 1 clinical trials where there are only limited data indicating its efficacy and safety."

Answered by AI

Is there an opportunity to participate in this clinical experiment?

"This clinical trial necessitates 30 individuals aged 3 to 45 suffering from lymphoma or Hodgkin's disease, who have been classified as CR1-ultra high risk, hypodiploidy positive, and/or possess one of the other CR3 qualifiers."

Answered by AI
~1 spots leftby Jul 2024