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iCaspase9-transduced T cells + AP1903 for Blood Cancers (DOTTI Trial)

Phase 1

Waitlist Available

Led By Malcolm K Brenner, MB, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absence of severe renal disease (creatinine > 2X upper limit of normal for age)

Greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of original disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

DOTTI Trial Summary

This trial is for patients who are undergoing an allogeneic stem cell transplant for the treatment of their disease.

Who is the study for?

This trial is for patients with certain blood disorders or immune system conditions like Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome, and various forms of Leukemia. Participants must have a life expectancy over 30 days, stable organ function, and no severe infections. Pregnant individuals or those on other investigational drugs within the last 30 days cannot join.Check my eligibility

What is being tested?

The study tests genetically modified T cells with a 'suicide gene' (iCasp9) in patients undergoing allogeneic stem cell transplants. If these T cells cause GvHD—a serious transplant complication—the drug AP1903 can be used to destroy them. The goal is to find a safe dose that helps immune recovery without causing harm.See study design

What are the potential side effects?

Potential side effects include development of GvHD if the suicide mechanism fails, reactions related to the infusion of modified T cells or AP1903 administration, and typical risks associated with stem cell transplantation such as infection due to weakened immunity.

DOTTI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal, with creatinine levels not exceeding twice the upper limit.

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My transplant shows at least 50% donor cells in blood or bone marrow, or my original disease has returned.

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I can care for myself but may need occasional help.

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My liver functions are within normal limits.

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I have a high-risk blood disorder like leukemia or lymphoma.

DOTTI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical and immunological effects of AP1903 administration.

Secondary outcome measures

Immune reconstitution and relative contribution of iCaspase9-modified T cells post-infusion.

Overall and disease-free survival.

T cell dose that produces a greater than 25% risk of Grade II or greater GvHD.

DOTTI Trial Design

1Treatment groups

Experimental Treatment

Group I: iCaspase9-transduced T cellsExperimental Treatment2 Interventions

The 5 dose levels are: 1 x 10^4 T cells/kg 1 x 10^5 T cells/kg 5 x 10^5 T cells/kg 1 x 10^6 T cells/kg 5 x 10^6 T cells/kg AP1903 will be administered if there is development of Grade 1 or greater GvHD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rimiducid

Not yet FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,165 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,360 Total Patients Enrolled

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,802 Total Patients Enrolled

Media Library

iCaspase9-transduced T cells Clinical Trial Eligibility Overview. Trial Name: NCT01494103 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: iCaspase9-transduced T cells

Acute Lymphoblastic Leukemia Clinical Trial 2023: iCaspase9-transduced T cells Highlights & Side Effects. Trial Name: NCT01494103 — Phase 1

iCaspase9-transduced T cells 2023 Treatment Timeline for Medical Study. Trial Name: NCT01494103 — Phase 1

Frequently Asked Questions

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

Has AP1903 been granted regulatory endorsement by the FDA?

"The degree of safety attributed to AP1903 is a cautiously low 1. This Phase 1 trial has only amassed limited data concerning safety and efficacy."

Answered by AI

What other examinations have been conducted concerning AP1903?

"Presently, AP1903 is being trialled in 16 different studies; however, none of these are at the Phase 3 stage. Although most trials for this drug take place in San Diego, California there are 94 sites running research for its efficacy."

Answered by AI

What is the patient count for this research endeavor?

"Unfortunately, this trial has closed recruitment. It was first listed on November 1st 2011 and the information was last modified on July 22nd 2022. For those searching for other trials, there are currently 3645 studies enrolling patients with Epstein-Barr virus infections and 16 active clinical trails to assess AP1903's efficacy."

Answered by AI

Is this investigation actively enrolling participants?

"The clinical trial detailed on clinicaltrials.gov is no longer enrolling participants, with the initial posting taking place back in November 2011 and its most recent edit occurring 22nd July 2022. However, there are over three thousand six hundred other studies currently looking for volunteers to participate in them."

Answered by AI

Recent research and studies

BloodJournal

Inducible Caspase-9 Suicide Gene Controls Adverse Effects from Alloreplete T Cells After Haploidentical Stem Cell Transplantation

Zhou, Xiaoou, Gianpietro Dotti, Robert A. Krance, Caridad A. Martinez, Swati Naik, Rammurti T. Kamble, April G. Durett, et al.. 2015. “Inducible Caspase-9 Suicide Gene Controls Adverse Effects from Alloreplete T Cells After Haploidentical Stem Cell Transplantation”. Blood. American Society of Hematology. doi:10.1182/blood-2015-02-628354.

clinicaltrials.govStudy

Administration of Donor T Cells With the Caspase-9 Suicide Gene

Malcolm Brenner 2011. "Administration of Donor T Cells With the Caspase-9 Suicide Gene". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01494103.

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