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Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma

NCT03168438 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-01-11

Study results available
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Summary

This trial will evaluate safety, tolerability, and efficacy of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with relapsed and refractory multiple myeloma.

Conditions

  • Neoplasms

Interventions

DRUG

Letetresgene autoleucel

Letetresgene autoleucel (GSK3377794) as an IV infusion

DRUG

Letetresgene autoleucel with pembrolizumab

Letetresgene autoleucel (GSK3377794) as an IV infusion, followed by pembrolizumab every 3 weeks

DRUG

Fludarabine

Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.

DRUG

Cyclophosphamide

Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.

DRUG

Pembrolizumab

Pembrolizumab is available as an IV infusion

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2020-07-13
Completion
2020-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168438 on ClinicalTrials.gov