Actively Recruiting
A Phase 2 Study to Evaluate CD19-Specific Chimeric Antigen Receptor (CAR)-T Cells Combined With Acalabrutinib for Patients With Relapsed or Refractory Mantle Cell Lymphoma
Led by City of Hope Medical Center ยท Updated on 2025-11-26
36
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of combining CD19-specific CAR T cells with acalabrutinib to treat patients with mantle cell lymphoma that has returned or not responded to previous treatments. This phase II trial aims to assess side effects and the complete response rate within six months after treatment, while also studying progression-free survival, overall survival, and the persistence and activity of the CAR T cells. Participants receive acalabrutinib orally twice daily starting five days before and continuing through 28 days of each cycle, repeating every 28 days for up to six cycles if no disease progression or unacceptable side effects occur. On day 0, patients are given CD19 CAR T cells intravenously. Those who have not achieved complete response after the first assessment and tolerated the initial CAR T infusion may receive a second CAR T cell infusion during the second cycle. During the study, participants will undergo regular assessments including disease evaluations, laboratory tests, and monitoring for side effects. Follow-up visits occur at 3, 6, and 12 months after treatment, then annually for up to 15 years to monitor long-term outcomes and safety. Researchers will measure toxicities, response rates, survival rates, and immune cell activity throughout the study period.
CONDITIONS
Brief Title
Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign written informed consent
- Agree to allow use of archival tissue from diagnostic tumor biopsies (exceptions may apply)
- Age 18 to 75 years
- ECOG performance status of 2 or less, or Karnofsky Performance Status of 70% or higher
- Documented CD19-positive mantle cell lymphoma by biopsy or flow cytometry
- Currently receiving acalabrutinib for 3 to 7 months prior to screening
- Have had at least one prior treatment regimen (excluding corticosteroids alone)
- Measurable disease by CT scan or evidence of involvement in blood, spleen, skin, gastrointestinal tract, or bone marrow
- No contraindications to leukapheresis, steroids, or tocilizumab
- Meet specified laboratory criteria including bilirubin, blood counts, liver enzymes, kidney function, coagulation measures
- Negative pregnancy test for females of childbearing potential
- Cardiac function within defined limits
- Agree to use effective birth control during treatment and for specified times after final doses
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 unless switched to acalabrutinib within specified duration
- Known mutations associated with resistance to BTK inhibitors
- Current use of systemic steroids or chronic immunosuppressants (some exceptions apply)
- Use of anti-cancer therapies other than acalabrutinib after enrollment (some exceptions apply)
- Treatment requiring strong CYP3A4 inhibitors or inducers
- Unable to stop warfarin or equivalent anticoagulants before leukapheresis
- Severe cardiovascular conditions or unstable arrhythmias
- Active autoimmune disease requiring systemic immunosuppression
- Progressive multifocal leukoencephalopathy
- Major surgery within 28 days prior to study drug
- History of optic neuritis or certain central nervous system diseases
- Hypersensitivity to study agents
- Gastrointestinal conditions affecting absorption or prior major surgeries affecting gut function
- Known bleeding disorders
- Recent stroke or brain hemorrhage
- Other malignancies unless treated and in remission
- Lactating women
- Active chronic graft-versus-host disease post-allogeneic transplant
- Uncontrolled active infections including HIV, hepatitis B or C, or other significant infections
- Any condition judged by investigator to contraindicate participation
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive acalabrutinib orally twice daily starting 5 days before the CAR T cell infusion and continuing in 28-day cycles for up to 6 cycles. They receive CD19 CAR T cells intravenously on day 0. A second CAR T cell infusion may be given in cycle 2 if needed.
Frequent visits during each 28-day cycle including day 0 infusion and assessments
Duration - Up to 15 years
After completing treatment, participants are followed up to monitor response, survival, and any long-term effects. Follow-up visits occur at 3, 6, and 12 months, then yearly for up to 15 years.
Visits at 3, 6, and 12 months post-treatment, then yearly visits
Trial Site Locations
Total: 1 location
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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