NCT07569965

Brief Summary

FRONTIER is a prospective, single arm, open label, multi-center, Phase II study of MB-CART2019.1 (Zamtocabtagene Autoleucel) therapy as frontline consolidation for high-risk Mantle Cell Lymphoma (MCL) participants

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
43mo left

Started Sep 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Mantle Cell Lymphoma (MCL)

Keywords

CD19/CD20-directed CAR-T CellsZamtocabtagene autoleucelB-Cell Non-Hodgkin LymphomaChimeric Antigen ReceptorCARCAR-T CellLymphoma, Non-HodgkinLymphoma, B-CellMCLImmunotherapyT cell infusionHigh-riskMantle Cell LymphomaFrontlineTP53

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    The primary endpoint is PFS at 1-year following MB2019.1 CAR T cell infusion. PFS is defined as the time interval from CAR T cell infusion until a PFS event occurs.

    1 year post-infusion

Secondary Outcomes (7)

  • Treatment Response

    1 year

  • Overall Survival (OS)

    1 year post-infusion

  • Duration of Complete Response (DOCR)

    1 year post-infusion

  • Non-relapse Mortality (NRM)

    1 year post-infusion

  • Relapse/progression

    1 year post-infusion

  • +2 more secondary outcomes

Study Arms (1)

Single, open label

EXPERIMENTAL
Biological: zamtocabtagene autoleucel (MB-CART2019.1)Drug: CyclophosphamideDrug: Fludarabine

Interventions

CyclophosphamideDRUG

Lymphodepleting chemotherapy

Single, open label
FludarabineDRUG

Lymphodepleting chemotherapy

Single, open label
zamtocabtagene autoleucel (MB-CART2019.1)BIOLOGICAL

chimeric antigen receptor T-cell (CAR-T) therapy

Single, open label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of MCL requires histologic confirmation by either overexpression of cyclin D1 OR presence of t(11;14) (q13; q32) translocation
  • Subject should have a tumor biopsy sample (at least 5 unstained slides of tissue or tissue block) available prior to MB-CART2019.1 infusion, preferably collected pre-induction.
  • If archival tissue is not available, the patient may be enrolled after discussion with the protocol chair and/or protocol officer
  • High Risk Disease at diagnosis, defined as having at least ONE of the criteria below:
  • High risk MIPI-c (as calculated by https://www.european-mcl.net/home/scores-mipi-mipi-c-19.html)
  • Simplified MIPI high-risk ≥6.2
  • TP53 mutation OR ≥50% TP53 expression by IHC
  • Complex Karyotype \[e.g. 3 or more cytogenetic abnormalities, excluding the presence or absence of t(11:14)\]
  • Ki67≥ 50%
  • Blastoid or pleomorphic histology with Ki-67 ≥30%
  • Leptomeningeal Disease at diagnosis
  • NOTCH1 mutation
  • Received 2 cycles of appropriate systemic induction therapy, which includes a CD20 antibody +/- cytotoxic therapy +/- oral targeted therapy (e.g., BTKi, immunomodulatory imid drugs), with the following considerations:
  • CD20 antibody alone does not count towards a cycle of treatment
  • Induction cycles do not have to be identical
  • +8 more criteria

You may not qualify if:

  • Unable to give informed consent
  • Any disease progression that occurs during the first 2 induction cycles
  • A creatinine clearance (as estimated by direct urine collection, Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\], or Cockcroft-Gault Equation or institutional standard) \< 45 mL/min
  • Cardiac ejection fraction (EF) \< 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Acquisition scan (MUGA) (if range is provided, the upper value of the range may be used for assessing eligibility)
  • Resting O2 saturation \< 92% on room air
  • Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST) ≥ 5 times the Upper Limit of Normal (ULN) for age
  • Total bilirubin \>1.5 mg/dL, except in individuals with Gilbert's syndrome
  • Absolute neutrophil count (ANC) \< 1000/μL unless related to bone marrow infiltration by mantle cell lymphoma. No short-acting granulocyte colony-stimulating factor (G-CSF) use within 7 days of ANC evaluation
  • Platelet count \< 50,000/µL unless related to bone marrow infiltration or hypersplenism by mantle cell lymphoma. No transfusions within 7 days of assessment.
  • Absolute CD3 count \< 50/μL at screening
  • Absolute lymphocyte count (ALC) \< 100/μL within 7 days of apheresis
  • Known history of infection with human immunodeficiency virus (HIV)
  • Known active infection with hepatitis B (hepatitis B surface antigen \[HBsAg\] positive). If there is a history of treated hepatitis B, the viral load must be polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-hepatitis B core (HBc) positive
  • Known active infection with hepatitis C virus (anti-HCV antibody positive). If patient has a positive hepatitis C antibody, the viral load must be undetectable per quantitative PCR and/or nucleic acid testing
  • No seizure history within 6 months prior to enrollment
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lymphoma, Mantle-CellLymphoma, B-CellLymphoma, Non-Hodgkin

Interventions

Cyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Sadie Swift

CONTACT

617-218-0044clinicaltrials@miltenyi.com

Erick Flores

CONTACT

617-218-0044clinicaltrials@miltenyi.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 6, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

March 1, 2030

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share