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Bruton's Tyrosine Kinase (BTK) Inhibitor

CD19 CAR T-Cells + Acalabrutinib for Mantle Cell Lymphoma

Phase 2
Recruiting
Led By Lihua E Budde
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Left ventricular ejection fraction > 40%
Documented CD19+ mantle cell lymphoma (MCL) by flow cytometry or immunohistochemistry (IHC) (from biopsy) if prior CD19 directed therapy was previously used
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 year post car t cell infusion
Awards & highlights

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.

Who is the study for?
This trial is for patients with Mantle Cell Lymphoma that has returned or isn't responding to treatment. They must have CD19+ MCL, measurable disease, normal liver and kidney function, and be on acalabrutinib for 3-7 months with at least one failed prior regimen. Participants need a good performance status, no major surgeries recently, not pregnant or breastfeeding, and willing to use birth control.Check my eligibility
What is being tested?
The trial tests modified immune cells (CD19 CAR T Cells) combined with Acalabrutinib in treating relapsed/refractory Mantle Cell Lymphoma. The patient's own T cells are engineered to target the CD19 protein on cancer cells while Acalabrutinib aims to block enzymes needed for cancer cell growth.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever and fatigue; organ inflammation; infusion-related reactions; blood disorders; increased risk of infections due to weakened immunity; and possible complications from the underlying conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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My heart pumps well enough (ejection fraction over 40%).
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My lymphoma is CD19 positive, confirmed by tests.
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I have been taking acalabrutinib for 3-7 months.
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I have tried at least one treatment before acalabrutinib, not counting steroids.
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My kidneys are functioning well, with a creatinine clearance rate of at least 50 mL/min.
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I am mostly able to care for myself and remain up and about more than 50% of my waking hours.
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My cancer responded to acalabrutinib with minimal residual disease, partial or stable response.
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My disease can be seen on a CT scan or affects my blood or bone marrow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 year post car t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 year post car t cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) (Phase II)
Occurrence of dose-limiting toxicities (DLTs) (Safety Lead-in)
Secondary outcome measures
Best response
Duration of CR
Incidence of adverse events
+3 more
Other outcome measures
CD19 CAR T cell persistence
Duration of CR from completion of acalabrutinib
Presence of CD19CAR immunogenicity

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CD19 CAR T cells, acalabrutinib)Experimental Treatment2 Interventions
Patients receive acalabrutinib PO BID on days -5 to 28 of cycle 1 and on days 1-28 of subsequent cycles. Patients also receive CD19 CAR T cells IV on day 0. Treatment with acalabrutinib repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not attained CR after the first disease assessment and tolerated the initial CAR T cell infusion may receive a second CAR T cell infusion in cycle 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,097 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,424 Total Patients Enrolled
Lihua E BuddePrincipal InvestigatorCity of Hope Comprehensive Cancer Center
1 Previous Clinical Trials

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04484012 β€” Phase 2
Mantle Cell Lymphoma Research Study Groups: Treatment (CD19 CAR T cells, acalabrutinib)
Mantle Cell Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04484012 β€” Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04484012 β€” Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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)."

Answered by AI
~3 spots leftby Sep 2024