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CAR T-cell Therapy
CART-38 for Acute Myeloid Leukemia and Multiple Myeloma
Phase 1
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documentation of CD38 Expression on leukemic blasts by flow or by immunohistochemistry (IHC)
ECOG Performance Status that is either 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial tests a new CAR T cell therapy for treating Acute Myeloid Leukemia and Multiple Myeloma. It checks safety and manufacturing feasibility of the treatment.
Who is the study for?
Adults over 18 with Acute Myeloid Leukemia or Multiple Myeloma, who have a backup option for cell transplant and good organ function. They must not be dependent on steroids, pregnant, or have certain heart issues, active infections, CNS diseases, GVHD requiring therapy, autoimmune diseases needing high-dose steroids, or known allergies to the study product components.Check my eligibility
What is being tested?
The trial is testing CART-38 cells in patients with AML and MM. These are T cells modified to target CD38 cancer markers using a new method. Different doses of these cells will be given after chemotherapy drugs Cyclophosphamide and Fludarabine to evaluate safety and production feasibility.See study design
What are the potential side effects?
Potential side effects include immune system reactions that can affect normal organs (like inflammation), infusion-related reactions from the T-cell transfer process itself such as fever or chills, fatigue due to treatment intensity, blood count changes leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia cells show CD38 expression.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have cells saved for a backup treatment if needed.
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It's been over 3 months since my last self-donor transplant and over 6 months since my transplant from another person.
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I am 18 years old or older.
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I have either AML with specific criteria or relapsed/refractory MM.
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
Determination of maximum tolerated dose assessed by collection of adverse events as graded by CTCAE.
Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Number of subjects with dose-limiting toxicities
Secondary outcome measures
Frequency of manufacturing failures as determined by production of study treatment that meets protocol defined targeted dose
Overall Response Rate (ORR)
Overall Survival (OS)
+3 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Cohort B Dose Level 3: Multiple Myeloma (MM)Experimental Treatment3 Interventions
Cohort B Dose Level 3 - Adult patients ages ≥ 18 with Multiple Myeloma (MM) who have not achieved remission after at least two lines of prior therapy will receive a single fixed dose of 3x10(7) CART 38 Cells via intravenous infusion on Day 0, following lymphodepleting chemotherapy with cyclophosphamide or fludarabine based on physician discretion.
Group II: Cohort B Dose Level 2: Multiple Myeloma (MM)Experimental Treatment3 Interventions
Cohort B Dose Level 2 - Adult patients ages ≥ 18 with Multiple Myeloma (MM) who have not achieved remission after at least two lines of prior therapy will receive a single fixed dose of 7x10(6) CART 38 Cells via intravenous infusion on Day 0, following lymphodepleting chemotherapy with cyclophosphamide or fludarabine based on physician discretion.
Group III: Cohort B Dose Level 1: Multiple Myeloma (MM)Experimental Treatment3 Interventions
Cohort B Dose Level 1 - Adult patients ages ≥ 18 with Multiple Myeloma (MM) who have not achieved remission after at least two lines of prior therapy will receive a single fixed dose of 3x10(6) CART 38 Cells via intravenous infusion on Day 0, following lymphodepleting chemotherapy with cyclophosphamide or fludarabine based on physician discretion.
Group IV: Cohort B Dose Level -1: Multiple Myeloma (MM)Experimental Treatment3 Interventions
Cohort B Dose Level -1 - Adult patients ages ≥ 18 with Multiple Myeloma (MM) who have not achieved remission after at least two lines of prior therapy will receive a single fixed dose of 7x10(5) CART 38 Cells via intravenous infusion on Day 0, following lymphodepleting chemotherapy with cyclophosphamide or fludarabine based on physician discretion.
Group V: Cohort A Dose Level 3 :Relapsed/Refractory Acute Myeloid Leukemia (AML)Experimental Treatment3 Interventions
Cohort A Dose Level 3: Adult patients ages ≥ 18 with acute myeloid leukemia (AML) will receive a single fixed dose of 3x10(7) CART 38 Cells via intravenous infusion on Day 0, following lymphodepleting chemotherapy with cyclophosphamide or fludarabine based on physician discretion.
Group VI: Cohort A Dose Level 2 :Relapsed/Refractory Acute Myeloid Leukemia (AML)Experimental Treatment3 Interventions
Cohort A Dose Level 2: Adult patients ages ≥ 18 with acute myeloid leukemia (AML) will receive a single fixed dose of 7x10(6) CART 38 Cells via intravenous infusion on Day 0, following lymphodepleting chemotherapy with cyclophosphamide or fludarabine based on physician discretion.
Group VII: Cohort A Dose Level 1: Relapsed/Refractory Acute Myeloid Leukemia (AML)Experimental Treatment3 Interventions
Cohort A Dose Level 1: Adult patients ages ≥ 18 with acute myeloid leukemia (AML) who have not achieved remission after at least two lines of prior therapy will receive a single fixed dose of 3x10(6) CART 38 Cells via intravenous infusion on Day 0, following lymphodepleting chemotherapy with cyclophosphamide or fludarabine based on physician discretion.
Group VIII: Cohort A Dose Level -1 :Relapsed/Refractory Acute Myeloid Leukemia (AML)Experimental Treatment3 Interventions
Cohort A Dose Level -1: Adult patients ages ≥ 18 with acute myeloid leukemia (AML) will receive a single fixed dose of 7x10(5) CART 38 Cells via intravenous infusion on Day 0, following lymphodepleting chemotherapy with cyclophosphamide or fludarabine based on physician discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,251 Total Patients Enrolled
13 Trials studying Multiple Myeloma
343 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to some ingredients in the study medication.I do not have any ongoing, untreated infections.My leukemia cells show CD38 expression.I am fully active or restricted in physically strenuous activity but can do light work.I am taking strong medication for an autoimmune disease.I have cells saved for a backup treatment if needed.I have a history of optic neuritis or an immune-related brain disease not caused by cancer or its treatment.My cancer has a JAK2 V617F mutation.I am currently receiving treatment for ongoing GVHD.I have severe heart condition limitations.It's been over 3 months since my last self-donor transplant and over 6 months since my transplant from another person.My organs are working well.I am 18 years old or older.I have an active brain or spinal cord disease.I rely on steroids or immunosuppressant drugs for my health.I have active hepatitis B or C.I have either AML with specific criteria or relapsed/refractory MM.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B Dose Level -1: Multiple Myeloma (MM)
- Group 2: Cohort B Dose Level 1: Multiple Myeloma (MM)
- Group 3: Cohort A Dose Level 2 :Relapsed/Refractory Acute Myeloid Leukemia (AML)
- Group 4: Cohort A Dose Level -1 :Relapsed/Refractory Acute Myeloid Leukemia (AML)
- Group 5: Cohort A Dose Level 3 :Relapsed/Refractory Acute Myeloid Leukemia (AML)
- Group 6: Cohort B Dose Level 3: Multiple Myeloma (MM)
- Group 7: Cohort B Dose Level 2: Multiple Myeloma (MM)
- Group 8: Cohort A Dose Level 1: Relapsed/Refractory Acute Myeloid Leukemia (AML)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How risky is Cohort B Dose Level 2: Multiple Myeloma (MM) for individuals?
"Cohort B Dose Level 2: Multiple myeloma (MM) safety is rated 1 since it is a Phase 1 trial, meaning the data supporting efficacy and security are sparse."
Answered by AI
Is there availability within this clinical trial for new enrollees?
"Affirmative. According to clinicaltrials.gov, this medical trial which was launched on May 1st 2023 is currently recruiting patients. 36 participants must be registered from a single site."
Answered by AI
How many people are participating in this medical experiment?
"Indeed, the clinicaltrials.gov database affirms that this medical trial is actively seeking out participants. It was initially listed on May 1st 2023 and has been updated most recently on May 24th 2023. In total, 36 patients need to be sourced from one location for successful completion of this study."
Answered by AI
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