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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

Must not have

Severe intercurrent infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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).

Exclusion Criteria

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

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I do not have a severe ongoing infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

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

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

Primary study objectives

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 study objectives

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.

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