huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia

Summary

This phase I trial studies the side effects of huJCAR014 in treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia. huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a patient's T cells and may specifically kill cancer cells that have a molecule CD19 on their surfaces.

In Stage 1, dose-finding studies will be conducted in 3 cohorts:

1. Aggressive B cell NHL
2. Low burden ALL
3. High burden ALL

In Stage 2, studies may be conducted in one or more cohorts to collect further safety, PK, and efficacy information at the huJCAR014 dose level(s) selected in Stage 1 for the applicable cohort(s). There are two separate cohorts for stage 2:

1. Cohort 2A, CAR-naïve (n=10): patients who have never received CD19 CAR-T cell therapy.
2. Cohort 2B, CAR-exposed (n=27): patients who have previously failed CD19 CAR-T cell therapy.

Conditions

• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
• Refractory Adult Acute Lymphoblastic Leukemia
• Refractory B-Cell Non-Hodgkin Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
• Recurrent Transformed Non-Hodgkin Lymphoma
• Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Recurrent B Acute Lymphoblastic Leukemia
• Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• Refractory B Acute Lymphoblastic Leukemia
• Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements

Interventions

BIOLOGICAL

Autologous Human Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ T-lymphocytes

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Leukapheresis

Undergo leukapheresis

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

  collaborator INDUSTRY

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Jordan Gauthier · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-03

Primary Completion

2023-03-23

Completion

2024-03-23

FDA Drug

Yes

Countries

• United States

Study Locations