Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06026319

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2026-03-16

24

Participants Needed

1

Research Sites

218 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research study involves the study of CD79b-19 CAR T cells for treating people with relapsed/refractory Non-Hodgkin Lymphoma and to understand the side effects when treated with CD79b-19 CAR T cells. This research study involves the study drugs: * CD79b-19 CAR T cells * Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process

CONDITIONS

Official Title

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Signed informed consent form(s) voluntarily
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky 80%)
  • Diagnosis of relapsed or refractory Non-Hodgkin lymphoma, including specific subtypes with defined prior treatment lines
  • Measurable disease according to appropriate criteria
  • Adequate absolute lymphocyte count (>100 cells/ul) within one week of apheresis
  • Adequate bone marrow function with ANC >1000 cells/mm3 without growth factor support and platelet count >50,000/mm3
  • Left ventricular ejection fraction >40%
  • Adequate liver function (AST and ALT <2.5 times upper limit of normal, direct bilirubin <1.5 times ULN)
  • Adequate renal function with creatinine clearance >60 ml/min
  • Use of adequate contraception for women of child-bearing potential and men with partners of childbearing potential
  • Willingness and ability to follow study visit schedule and protocol requirements
  • For treatment initiation: ECOG 0-2, no active uncontrolled infection, oxygen saturation >92% on room air, no additional anti-cancer therapy since leukapheresis except low-dose steroids
Not Eligible

You will not qualify if you...

  • Treatment with any investigational cellular therapy within 8 weeks before apheresis
  • Systemic anti-cancer therapy within 1 week or 5 half-lives before leukapheresis, excluding low-dose steroids
  • Use of bispecific T cell engagers or bendamustine within 6 months before leukapheresis
  • Ongoing chronic immunosuppressant treatment above physiologic dosing
  • Systemic immunosuppression for graft-versus-host disease within 12 weeks of prior allogeneic stem cell transplant
  • Active central nervous system (CNS) disease
  • Significant medical conditions posing undue risk or interfering with study
  • Active uncontrolled systemic infections
  • History of severe heart failure or certain cardiac conditions within 3 months
  • Recent pulmonary embolism or deep vein thrombosis within 6 months requiring anticoagulation
  • Second malignancies requiring therapy within 3 years or not in remission except certain skin or prostate cancers
  • Pregnant or lactating women
  • Prior CD19-directed cellular therapy (for Part B, Arm B.2)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

M

Matthew Frigault, MD

CONTACT

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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CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma | DecenTrialz