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CAR T-cell Therapy

Allodepleted T Cells for Leukemia (CASPALLO Trial)

Phase 1
Waitlist Available
Led By Malcolm K Brenner, MD
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
Lack of suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor
Must have greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

CASPALLO Trial Summary

This trial is testing a way to treat GvHD using a new drug. Patients will be given the drug as part of their stem cell transplant treatment.

Who is the study for?
This trial is for patients with certain blood disorders like leukemia, who are getting a stem cell transplant and have no perfect match donor. They should not be pregnant, must have a life expectancy over 30 days, stable liver and kidney function, good oxygen levels without assistance, and an ability to consent. It's not for those with severe infections or recent other investigational drug use.Check my eligibility
What is being tested?
The study tests allodepleted T cells modified with the iCasp9 'suicide gene' in patients receiving non-matched stem cell transplants. If GvHD occurs—a common serious side effect—the modified T cells can be targeted and killed using the experimental drug AP1903 to prevent harm.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion of modified T cells or AP1903 activation such as fever or chills. There may also be risks from graft-versus-host disease if the treatment doesn't work as expected.

CASPALLO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have a closely matched donor or my disease is worsening too quickly.
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My transplant shows at least 50% donor cells, or my original disease has returned.
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My kidney function is not severely impaired.
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I am 65 or younger with advanced leukemia or lymphoma that has not responded to treatment.
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I have a condition related to an overactive immune response, such as HLH or a related disorder.
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I can do most activities but may need help.
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My liver functions are within normal limits.
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My AML has returned after treatment or did not respond to initial treatment.
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I have been diagnosed with Myelodysplastic syndrome.
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I have chronic myeloid leukemia (CML).

CASPALLO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
To determine the maximum number of suicide gene-modified allodepleted donor lymphocytes that can be given to recipients of haploidentical stem cell transplants that will result in a rate of Grade III/IV GVHD of 25% or less.
Secondary outcome measures
To analyze the contribution of the gene-modified cells to immune reconstitution in these patients by measuring their survival, persistence and expansion.
To evaluate the biological effects of administration of AP1903, a dimerizer used to activate the suicide gene mechanism, and its clinical effects in patients who develop GvHD.
To measure the overall and disease-free survival at 100 days and at 1 year post-transplant.
+1 more

CASPALLO Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Level 1-3Experimental Treatment1 Intervention
Administration of suicide gene-modified allodepleted T cells.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
997 Previous Clinical Trials
6,002,009 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
270 Previous Clinical Trials
80,248 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,807 Total Patients Enrolled

Media Library

Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00710892 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Dose Level 1-3
Non-Hodgkin's Lymphoma Clinical Trial 2023: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene Highlights & Side Effects. Trial Name: NCT00710892 — Phase 1
Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00710892 — Phase 1

Frequently Asked Questions

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

What safety concerns should be taken into consideration when utilizing Allodepleted T Cells?

"The safety of allodepleted T Cells is tentatively rated as a 1 due to the limited amount of data collected during Phase 1 trials, which can provide some insight into efficacy but only preliminary evidence regarding safety."

Answered by AI

Is it still possible to join the experiment of this clinical trial?

"clinicaltrials.gov states that this research is not taking on any additional patients at the moment, despite having been initially posted in 2008 and edited as recently as July 22nd 2022. Despite this particular study's lack of recruitment opportunities, there are still 3111 other ongoing trials accepting volunteers presently."

Answered by AI
Recent research and studies
~1 spots leftby Mar 2025