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

This study is looking at how safe and effective a combination of two treatments, CD19 CAR T cells and acalabrutinib, is for people with mantle cell lymphoma that has returned or isn't responding to other treatments. CD19 CAR T cells are your own immune cells (T cells) that are specially modified in a lab to recognize and fight cancer cells that have a protein called CD19. Acalabrutinib is a medication taken by mouth that helps stop cancer cell growth. The study aims to see if adding these modified T cells to acalabrutinib treatment can lead to a complete response (meaning the cancer is no longer detectable) within six months. You can join if you are between 18 and 75 years old and are willing to provide a tissue sample from a past biopsy.

Study design
This is a Phase II interventional study planning to enroll 36 participants. It is designed to evaluate the safety and effectiveness of combining CD19 CAR T cells with acalabrutinib.
What's involved
You will receive acalabrutinib by mouth twice daily and CD19 CAR T cells through an IV infusion. Acalabrutinib treatment repeats every 28 days for up to 6 cycles.
Compensation
Not stated in the trial record.
Follow-up
The study will measure complete response within 6 months of CAR T-cell infusion and concurrent acalabrutinib therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04484012

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
City of Hope Medical Center
~36 participants
Updated 2025-11-26 on ClinicalTrials.gov
What's tested:AcalabrutinibCD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of dose-limiting toxicities (DLTs) (Safety Lead-in)
Measured over Day 0 up to 28 days after the first chimeric antigen receptor (CAR) T cell infusion
+1 more outcome measured

Conditions

Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma

Explore related trials

Mantle Cell LymphomaCD19 Gene

NCT04484012

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Comprehensive Cancer Center

    Duarte, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lihua E Budde · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Elizabeth L. Budde
[email protected]
626-218-0162
Email the study team

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Eligibility criteria

Inclusion

If unavailable, exceptions may be granted with Study PI approval. Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed.
Absolute Neutrophil count (ANC ≥1000 cells/ul)\*
Growth factor use within 7 days prior screening is not allowed
Platelet count ≥75,000/ul. Transfusion with 7 days prior to screening is not allowed\* \*Exception: participants with bone marrow involvement do not need to meet this criteria 10. AST \< 3 x ULN 11. ALT \< 3 x ULN 12. Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula 13. International Normalized Ratio (INR) OR Prothrombin (PT) ≤ 1.5 x ULN 14. Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN 15. Female of childbearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required 16. Cardiac function (12 lead-ECG): QTc must be ≤ 480 msec 17. Left ventricular ejection fraction \>40% 18. Oxygen saturation 92% or above at room air or DLCO of 40% of best predicted Contraception 19. Participants of reproductive potential must agree to use highly effective birth control methods throughout therapy and for 2 months after final CAR T cell infusion and/or 2 days after final acalabrutinib dose, whichever is later (See Section 5.12 and Appendix B).

Exclusion

HIV positive or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment.
Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded.
Subjects who are hepatitis B core antibody positive (or have a known history of HBV infection) should be monitored quarterly with a quantitative PCR test for HBV DNA. HBV monitoring should last until 12 months after last dose of study drug. Any subject with a rising viral load (above lower limit of detection) should discontinue study drug and have antiviral therapy instituted and a consultation with a physician with expertise in managing hepatitis B. Subjects who are core Ab positive at study enrollment are strongly recommended to start Entecavir before start and until completion of study treatment.
Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.
Subjects who are positive cytomegalovirus \[CMV\] DNA polymerase chain reaction \[PCR\]).
Subject with any active significant bacterial, fungal or viral (other than those listed) infections. 23. Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.
Eligibility should be confirmed per institutional policies.

What this trial measures

  • Occurrence of dose-limiting toxicities (DLTs) (Safety Lead-in)Day 0 up to 28 days after the first chimeric antigen receptor (CAR) T cell infusion

    Rates and associated 95% Clopper and Pearson exact confidence interval (CI) will be estimated for DLTs at the safe dose.

  • Complete response (CR) (Phase II)Within 6 months of CAR T-cell infusion and concurrent acalabrutinib therapy

    Response will be assessed based on Lugano classification. CR rate is defined as the proportion of response-evaluable participants who achieve a best response of CR within 6 months of CAR T-cell infusion and concurrent acalabrutinib therapy. Rates and associated 95% Clopper and Pearson exact CI will be estimated for CR within 6 months.