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Bruton's Tyrosine Kinase (BTK) Inhibitor
CD19 CAR T-Cells + Acalabrutinib for Mantle Cell Lymphoma
Duarte, CA
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
Must not have
Active chronic graft-versus-host disease (GVHD) post-allogeneic HCT
Active auto-immune disease requiring systemic immunosuppressive therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 year post car t cell infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating the side effects and efficacy of CD19 CAR T cells and acalabrutinib in treating patients with mantle cell lymphoma.
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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 “Yes” for the criteria belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am experiencing chronic GVHD after a stem cell transplant.
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I have an active autoimmune disease needing strong medication.
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I had a stem cell transplant using my own cells within the last 3 months.
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I have a heart rhythm problem that isn't controlled by medication.
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I have or might have a brain infection known as PML.
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My tests show mutations that resist BTK inhibitor treatments.
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I haven't had major surgery in the last 28 days or have fully recovered if I did.
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I have a condition that affects how my body absorbs food.
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I have not had a stroke or brain bleed in the last 6 months.
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I have had optic neuritis or another immune-related disease affecting my brain or spinal cord.
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I do not have any ongoing infections that aren't responding to treatment.
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I have a bleeding disorder like von Willebrand's or hemophilia.
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I do not have active hepatitis B as shown by my test results.
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I need treatment with a strong medication that affects liver enzymes.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 year post car t cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 year post car t cell infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response (CR) (Phase II)
Occurrence of dose-limiting toxicities (DLTs) (Safety Lead-in)
Secondary study objectives
Best response
Duration of CR
Incidence of adverse events
+3 moreOther study objectives
CD19 CAR T cell persistence
Duration of CR from completion of acalabrutinib
Presence of CD19CAR immunogenicity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2110
Find a Location
Closest Location:City of Hope Comprehensive Cancer Center· Duarte, CA· 1959 miles
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
14,054 Previous Clinical Trials
41,149,395 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
613 Previous Clinical Trials
1,924,003 Total Patients Enrolled
Lihua E BuddePrincipal InvestigatorCity of Hope Comprehensive Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CD19 CAR T cells, acalabrutinib)
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.