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CD19 CAR T-Cells + Acalabrutinib for Mantle Cell Lymphoma
Study Summary
This trial is investigating the side effects and efficacy of CD19 CAR T cells and acalabrutinib in treating patients with mantle cell lymphoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am experiencing chronic GVHD after a stem cell transplant.I have an active autoimmune disease needing strong medication.My heart pumps well enough (ejection fraction over 40%).You have had a severe allergic reaction or anaphylaxis to the study drug in the past.I had a stem cell transplant using my own cells within the last 3 months.I agree to let my previous biopsy samples be used for research.I have severe heart issues but can join if I have stable, symptom-free irregular heartbeat.I have a heart rhythm problem that isn't controlled by medication.I have or might have a brain infection known as PML.My tests show mutations that resist BTK inhibitor treatments.My lymphoma is CD19 positive, confirmed by tests.I have been taking acalabrutinib for 3-7 months.I have tried at least one treatment before acalabrutinib, not counting steroids.My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.I cannot stop taking my blood thinner medication for a week for a study procedure.I haven't had major surgery in the last 28 days or have fully recovered if I did.I had cancer before, but it was either fully removed, treated early, or has been inactive for over 3 years.I have a condition that affects how my body absorbs food.I am not on long-term steroids or immune-weakening drugs, except for low-dose or inhaled steroids.I am taking medication for acid reflux or heartburn.I have had optic neuritis or another immune-related disease affecting my brain or spinal cord.I am mostly able to care for myself and remain up and about more than 50% of my waking hours.I can safely undergo leukapheresis and take steroids or tocilizumab.I have not had a stroke or brain bleed in the last 6 months.I do not have any ongoing infections that aren't responding to treatment.I have a bleeding disorder like von Willebrand's or hemophilia.My cancer responded to acalabrutinib with minimal residual disease, partial or stable response.I had a stem cell transplant from a donor within the last 6 months.I do not have active hepatitis B as shown by my test results.I won't take any cancer treatments other than acalabrutinib after joining, except for steroids or specific radiation.I stopped a BTK inhibitor because it didn't work, except I switched from ibrutinib to acalabrutinib due to side effects.My disease can be seen on a CT scan or affects my blood or bone marrow.I agree to use effective birth control during and for 2 months after my treatment.I need treatment with a strong medication that affects liver enzymes.
- Group 1: Treatment (CD19 CAR T cells, acalabrutinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are researchers currently seeking participants for this experiment?
"This clinical trial, which was originally uploaded to the website on December 31st 2020 and revised on June 16th 2022, is currently accepting participants."
How many participants have enrolled in this clinical research?
"Affirmative. According to the information hosted on clinicaltrials.gov, this research initiative is actively recruiting patients at present time. This study initially opened its doors for recruitment in December of 2020 and was last updated in June 2022. The team behind it are currently searching for 36 participants from a single site."
What conditions have been demonstrated to be treatable through the application of CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes?
"The most effective treatment for renal dysfunction is CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes. This same therapeutic regimen can provide relief from other afflictions such as chronic lymphocytic leukemia (cll), kidney failure, and mantle cell lymphoma (mcl)."
What risks, if any, have been identified with CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes?
"The team at Power has assigned CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes a 2 on the safety scale, as this is only in its second phase of development and there is clinical evidence backing up its security but none that confirms efficacy."
Has a similar investigation been conducted previously?
"Research into CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes started back in 2007 and was funded by the Baxter Healthcare Corporation. After a successful Phase 4 drug trial of 4640 participants, 107 active clinical studies are now being conducted worldwide over 1220 cities and 49 countries."
What other experiments have explored the efficacy of CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes?
"At present, there are 107 clinical trials running for the CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes drug. Of these studies, 14 are in their final Phase 3 stage. While Boston hosts the majority of such experiments, 8859 other locations also participate in researching this medication."
Is the age restriction for enrolment in this trial greater than fifty-five years?
"The experimenters are seeking out participants aged 18 to 75. For those that don't meet this criteria, there is a selection of 316 studies for minors and 1666 options available to seniors."
Are there any particular demographics that would be advantageous to include in this research?
"This clinical trial is open to 36 patients aged between 18 and 75 who are suffering from treatment-resistant mantle cell lymphoma. The requisite prerequisites include having the proficiency to understand the informed consent agreement, granting permission for archived tissue samples to be used, an Eastern Cooperative Oncology Group performance status of 2 or higher/Karnofsky Performance Status greater than 70%, a positive diagnosis via flow cytometry & immunohistochemistry (if prior CD19 targeted therapy has been utilized), failure on at least one regimen before acalabrutinib, measurable disease by CT scan (>= 1.5 cm) or evidence of bone"
What is the aim of this research endeavor?
"The principal aim of this trial, conducted over a period of 6 months in which patients receive CAR-T cell infusions and concomitant acalabrutinib therapy, is to assess the occurrence rate of dose-limiting toxicities. Secondary outcomes include best response (defined as the highest documented result achieved at any time following infusion up until one year later or when non-protocol lymphoma treatments are initiated), progression free survival (assessed using Kaplan Meier methods) and time to complete remission (summarized with descriptive statistics)."
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