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CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

ConditionsNon-hodgkin LymphomaRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaFollicular LymphomaMarginal Zone LymphomaDiffuse Large B Cell LymphomaPrimary Mediastinal Large B-cell Lymphoma (PMBCL)High-grade B-cell LymphomaGrade 3b Follicular LymphomaMantle Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarcela V. Maus, M.D.,Ph.D.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign informed consent form(s)

≥18 years of age at the time of signing informed consent

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%)

Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a

Disqualifiers

Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.

Any systemic anti-cancer therapy within 1 weeks or 5 half-lives of leukapheresis, whichever is shortest, excluding steroids (prednisone) at or below physiologic dosing (5mg).

No bispecific T cell engagers within 6 months of leukapheresis.

No bendamustime within 6 months of leukapheresis.

Trial design

Design model

Single group

Treatments tested in this trial

  • CD79b-19 CAR T cells

    Drug

    Intravenous infusion

  • Cyclophosphamide

    Drug

    Intravenous infusion

  • Fludarabine

    Drug

    Intravenous infusion

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: CD79b-19 CAR T cellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Study-related adverse events (AEs) will be listed and tabulated by type and study cohort. The rate of AEs in all infused patients, both within study cohorts and overall, will be calculated and reported with exact 95% confidence intervals. A separate safety analysis will report similar information within patients infused at the target dose of 1x108 or 3x108 CD79b-19 CAR T cells.

Time frame
From Day 0 to 2 years post-treatment
2

Incidence of Dose Limiting Toxicity (DLT)

Dose-limiting toxicities will be listed and tabulated by type and study cohort.

Time frame
From Day 0 to 2 years post-treatment

Secondary outcomes

1

Overall Response Rate (ORR)

Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.

Time frame
1 month, 6 months, 12 months, and 24 months after CD79b-19 CAR T cells treatment
2

Overall Survival (OS)

Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.

Time frame
1 month, 6 months, 12 months, and 24 months after CD79b-19 CAR T cells treatment
3

Progression Free Survival (PFS)

Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.

Time frame
1 month, 6 months, 12 months, and 24 months after CD79b-19 CAR T cells treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marcela V. Maus, M.D.,Ph.D.

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Source ClinicalTrials.gov
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