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CAR T-cell Therapy
BCMA CAR-T Cell Therapy for Multiple Myeloma
Phase 1
Waitlist Available
Led By James N Kochenderfer, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A specific quantitative level of BCMA expression for eligibility is not specified, but patients with multiple myeloma cells that are negative for BCMA by flow cytometry and immunohistochemistry on either bone marrow biopsy or plasmacytoma biopsy will not be enrolled.
- A biopsy-proven plasmacytoma at least 2.0 cm in largest dimension.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each arm/group respectively.
Awards & highlights
Study Summary
This trial is testing whether it is safe to give changed T cells to people with multiple myeloma.
Who is the study for?
Adults aged 18-73 with multiple myeloma resistant to standard treatments, who have tried at least three different therapies including IMiDs and proteasome inhibitors. Participants must not be HIV or hepatitis positive, should have adequate organ function, and agree to use birth control. Those with certain other health conditions or treatments are excluded.Check my eligibility
What is being tested?
The trial is testing a gene therapy using the patient's own T cells that are modified in the lab to target cancer cells more effectively. It includes chemotherapy drugs Cyclophosphamide and Fludarabine followed by infusion of these engineered T cells.See study design
What are the potential side effects?
Potential side effects may include reactions from the chemotherapy such as nausea, hair loss, blood disorders; immune responses due to modified T cells like fever or fatigue; and risks associated with infusions such as infection at the site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma cells show some level of BCMA.
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I have a biopsy-proven plasmacytoma that is at least 2.0 cm big.
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I am between 18 and 73 years old.
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My hepatitis B test results are negative.
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I have tested negative for Hepatitis C.
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My cancer cells show BCMA presence, confirmed by tests on bone marrow or a tumor biopsy.
Select...
I have undergone 3 different treatments for multiple myeloma.
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I have been treated with drugs like lenalidomide and a proteasome inhibitor before.
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My white blood cell count is healthy without needing medication.
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It's been over 2 weeks since my last systemic therapy, and I've mostly recovered from its side effects.
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My heart pumps well and I don't have serious fluid around it.
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I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each arm/group respectively.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each arm/group respectively.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of Anti-B Cell Maturation Antigen (BCMA) - Chimeric Antigen Receptor (CAR)-T Cells
Number of Participants at Each Dose Level Who Experience a Dose-Limiting Toxicity (DLT)
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/Conditioning chemotherapy plus chimeric antigen receptors (CARs) T-cells expansion phaseExperimental Treatment3 Interventions
6.0x10^6 dose (maximum feasible dose) of CAR T Cells + Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Group II: 1/Conditioning chemotherapy plus chimeric antigen receptors (CARs) T-cells dose escalationExperimental Treatment3 Interventions
Patients will receive escalating doses (up to 5 planned) of CAR+ T cells infused on day 0 + Cyclophosphamide: 300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,118 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,695 Patients Enrolled for Multiple Myeloma
James N Kochenderfer, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
1,241 Total Patients Enrolled
3 Trials studying Multiple Myeloma
1,043 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My platelet count is above 55,000 without recent transfusions.I need urgent treatment because my tumor is pressing on my spine or other organs.I have multiple myeloma and no other cancer needing treatment in the last 3 years, except for certain skin cancers.I have an active autoimmune disease like psoriasis or rheumatoid arthritis.I have stored blood cells not modified by gene therapy.Less than half of my bone marrow cells are plasma cells.I have or had multiple myeloma in my brain or spinal fluid.My multiple myeloma cells show some level of BCMA.I have a biopsy-proven plasmacytoma that is at least 2.0 cm big.More than 30% of your bone marrow cells are plasma cells.I am between 18 and 73 years old.You do not have the HIV virus in your blood.My hepatitis B test results are negative.Your hemoglobin level is higher than 8.0 grams per deciliter.Your blood creatinine level is less than or equal to 1.5 mg/dL.I do not have any ongoing serious infections, blood clotting issues, or uncontrolled major illnesses.I haven't taken more than 5 mg/day of steroids like prednisone in the last 2 weeks.It's been over 2 weeks since my last systemic therapy, and I've mostly recovered from its side effects.I haven't taken high-dose steroids or myeloma treatments in the last 2 weeks.I have tested negative for Hepatitis C.I do not wish to receive intensive care treatments like ventilation or dialysis.I have spinal cord compression but no cancer in the spinal cord itself.I have had a stem cell transplant from a donor.I have not received genetically modified cells except in NCI gene therapy studies.Your blood test results for ALT and AST should not be more than 2.5 times the normal limit.I haven't needed extra oxygen in the last month, except for a treated infection.I have undergone 3 different treatments for multiple myeloma.I have been treated with drugs like lenalidomide and a proteasome inhibitor before.My white blood cell count is healthy without needing medication.My cancer cells show BCMA presence, confirmed by tests on bone marrow or a tumor biopsy.I agree to use birth control during and for four months after the study.I have active hemolytic anemia.There are very few plasma cells in your blood.You have a condition that weakens your immune system, like Severe Combined Immunodeficiency Disease.Patients must have multiple myeloma that can be measured using specific criteria.Your total bilirubin level should be less than 2.0 mg/dL, unless you have Gilbert's Syndrome, in which case it should be less than 3.0 mg/dL.I am not pregnant, breastfeeding, and have tested negative for pregnancy.My heart pumps well and I don't have serious fluid around it.I am taking blood thinners other than aspirin.Your blood test shows a certain level of a substance called free light chain, and the ratio of this substance is abnormal.You have a high level of M-protein in your blood.You have more than 200 milligrams of M-protein in your urine over a 24-hour period.I am able to get out of my bed or chair and move around.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Conditioning chemotherapy plus chimeric antigen receptors (CARs) T-cells dose escalation
- Group 2: 2/Conditioning chemotherapy plus chimeric antigen receptors (CARs) T-cells expansion phase
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What disorders can Anti-BCMA CAR T cells be used to alleviate?
"Anti-BCMA CAR T cells is a common treatment for multiple sclerosis and other medical conditions including mixed cell type lymphoma, acute leukemia, myelocytic leukaemia, and retinoblastoma."
Answered by AI
Are there still opportunities to take part in this experimental research?
"Unfortunately, this experiment is not currently enrolling participants. It was initially advertised on the 14th of September 2018 and last modified on the 16th of November 2022. For those seeking other trials to join, 818 studies recruiting patients with neoplasms or plasma cell are presently running alongside 889 active Anti-BCMA CAR T cells clinical trials."
Answered by AI
What is the current capacity for participants in this clinical experiment?
"Unfortunately, this clinical study is not presently accepting applications. Initially posted on September 14th 2018 and last updated November 16th 2022, it does not require additional enrolment at the moment. If you'd like to look for alternative trials, there are 818 investigations involving neoplasms and plasma cells looking for volunteers as well as 889 studies that involve Anti-BCMA CAR T cell treatments currently recruiting participants."
Answered by AI
Are there any prior investigations that explored the efficacy of Anti-BCMA CAR T cells?
"Presently, there are 889 existing clinical trials for Anti-BCMA CAR T cells with 161 of them located in Phase 3. As many as 28446 locations offer these trials, yet Philadelphia has the highest concentration of participating clinics."
Answered by AI
Is the age bracket for this research limited to those over 55 years of age?
"Qualified participants of this trial must range in age from 18 to 73 years. Notably, there are 357 studies enrolling those younger than 18 and 1469 for those older than 65."
Answered by AI
Has the FDA officially sanctioned Anti-BCMA CAR T cells for therapeutic use?
"The data that exists on Anti-BCMA CAR T cells suggests a fairly low safety score of 1 since this is only in its initial clinical trial phase and there are still limited reports supporting efficacy."
Answered by AI
Am I a viable candidate for this medical research experiment?
"Individuals with neoplasms and plasma cells between 18-73 years old are eligible to sign up for this medical trial. The enrolment goal is 35 participants."
Answered by AI
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