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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 belowSelect...
I don't have a closely matched donor or my disease is worsening too quickly.
Select...
My transplant shows at least 50% donor cells, or my original disease has returned.
Select...
My kidney function is not severely impaired.
Select...
I am 65 or younger with advanced leukemia or lymphoma that has not responded to treatment.
Select...
I have a condition related to an overactive immune response, such as HLH or a related disorder.
Select...
I can do most activities but may need help.
Select...
My liver functions are within normal limits.
Select...
My AML has returned after treatment or did not respond to initial treatment.
Select...
I have been diagnosed with Myelodysplastic syndrome.
Select...
I have chronic myeloid leukemia (CML).
CASPALLO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
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 moreCASPALLO 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
1,003 Previous Clinical Trials
6,003,060 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
275 Previous Clinical Trials
80,535 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,807 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have a closely matched donor or my disease is worsening too quickly.My transplant shows at least 50% donor cells, or my original disease has returned.My kidney function is not severely impaired.I have graft-versus-host disease.I am 65 or younger with advanced leukemia or lymphoma that has not responded to treatment.I have a condition related to an overactive immune response, such as HLH or a related disorder.I can do most activities but may need help.My liver functions are within normal limits.You have taken any experimental drugs within the last 30 days.I do not have a severe ongoing infection.My AML has returned after treatment or did not respond to initial treatment.I have been diagnosed with Myelodysplastic syndrome.I have chronic myeloid leukemia (CML).
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1-3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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