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Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL

NCT04155710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-12-24

No results posted yet for this study

Summary

This is a Phase 1/2, study evaluating IOV-2001 (Adoptive Cell Therapy) composed of autologous PBL (Peripheral Blood Lymphocytes) in patients with CLL/SLL, which has relapsed or is relapsing during treatment with ibrutinib or acalabrutinib.

Conditions

Interventions

BIOLOGICAL

IOV-2001

Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.

DRUG

Low dose IL-2

6 doses of subcutaneous (SC) LD-IL-2 (9 MIU every 8-12 hours) will follow the infusion of IOV-2001

DRUG

High dose IL-2

6 doses of IV HD-IL-2 (600,000 IU/kg Q8-12H will follow the infusion of IOV-2001

DRUG

IL-2

6 doses of IL-2 will follow the infusion of IOV-2001

Sponsors & Collaborators

  • Iovance Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Iovance Biotherapeutics Medical Monitor · Iovance Biotherapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2024-11-11
Completion
2024-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04155710 on ClinicalTrials.gov