Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT04484012

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Led by City of Hope Medical Center · Updated on 2025-11-26

36

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial investigates the side effects of CD19 chimeric antigen receptor (CAR) T cells and acalabrutinib, and to see how well they work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CD19, a protein on the surface of the cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19 positive cancer cells. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CD19 CAR T cells together with acalabrutinib may kill more cancer cells.

CONDITIONS

Official Title

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability and willingness to sign informed consent
  • Agreement to allow use of archival tumor tissue or approval for exception
  • Age 18 to 75 years
  • ECOG performance status 0 to 2 or Karnofsky score 70% or higher
  • Documented CD19-positive mantle cell lymphoma
  • Currently receiving acalabrutinib for 3 to 7 months
  • At least one prior treatment regimen (not including corticosteroids alone)
  • Measurable disease by CT scan or involvement of blood, spleen, skin, GI tract, or bone marrow
  • No contraindications to leukapheresis, steroids, or tocilizumab
  • Total serum bilirubin 2.0 mg/dL or less (with exceptions for Gilbert syndrome)
  • Absolute neutrophil count 1000 cells/µL or higher (growth factor use not allowed within 7 days prior)
  • Platelet count 75,000/µL or higher (except those with bone marrow involvement)
  • AST and ALT less than 3 times upper limit of normal
  • Creatinine clearance 50 mL/min or greater
  • INR or prothrombin time 1.5 times upper limit of normal or less
  • Activated partial thromboplastin time 1.5 times upper limit of normal or less
  • Negative pregnancy test for females of childbearing potential
  • QTc interval 480 msec or less on ECG
  • Left ventricular ejection fraction greater than 40%
  • Oxygen saturation 92% or higher on room air or DLCO 40% or greater of predicted
  • Agreement to use effective birth control during treatment and for 2 months after final CAR T infusion or 2 days after last acalabrutinib dose
Not Eligible

You will not qualify if you...

  • Allogeneic hematopoietic cell transplant within last 6 months
  • Autologous hematopoietic cell transplant within last 3 months
  • Prior failure of any BTK inhibitor therapy (exceptions if switched to acalabrutinib within 3 to 7 months)
  • Known mutations linked to resistance to BTK inhibitors
  • Use of systemic steroids or chronic immunosuppressive medications (inhaled steroids allowed)
  • Use of anti-cancer therapies other than acalabrutinib after enrollment (except steroids or radiation for disease control)
  • Need for strong cytochrome P450 3A4 inhibitors or inducers
  • Inability to stop warfarin or similar anticoagulants before leukapheresis and during study
  • Severe heart disability (Class III/IV) or unstable arrhythmias
  • Active autoimmune diseases requiring systemic immunosuppressants
  • Progressive multifocal leukoencephalopathy
  • Recent major surgery within 28 days prior to study drug
  • History of optic neuritis or inflammatory CNS disease
  • Known allergy or severe reaction to study drugs
  • Gastrointestinal conditions affecting absorption or prior major GI surgeries
  • Known bleeding disorders
  • Recent stroke or brain hemorrhage within 6 months
  • History of other cancers except certain treated or low-risk types
  • Lactating women
  • Active graft-versus-host disease after allogeneic transplant
  • Uncontrolled active infections including HIV, hepatitis B or C, CMV, or significant bacterial, fungal, or viral infections
  • Any condition judged by investigator to make participation unsafe
  • Inability to comply with study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here