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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

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.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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

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

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 more

Other 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

~2080

0 / 22Eligibility criteria met