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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

Must not have

GvHD

Severe intercurrent infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have graft-versus-host disease.

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I am currently suffering from a severe infection.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical and immunological effects of AP1903 administration.

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: iCaspase9-transduced T cellsExperimental Treatment2 Interventions

The 5 dose levels are: 1. 1 x 10\^4 T cells/kg 2. 1 x 10\^5 T cells/kg 3. 5 x 10\^5 T cells/kg 4. 1 x 10\^6 T cells/kg 5. 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 / 7Eligibility criteria met