A Safety Study of SGN-CD19A for B-Cell Lymphoma

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Seagen

Status and phase

Completed
Phase 1

Conditions

Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Burkitt Lymphoma
Precursor B-cell Lymphoblastic Leukemia-Lymphoma

Treatments

Drug: SGN-CD19A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01786135
SGN19A-002

Details and patient eligibility

About

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)

Enrollment

64 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma
  • Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.
  • Eastern Cooperative Oncology Group status of 0 or 1
  • Measurable disease

Exclusion criteria

  • Allogeneic stem cell transplant (SCT)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

64 participants in 1 patient group

SGN-CD19A
Experimental group
Description:
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Treatment:
Drug: SGN-CD19A

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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