QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma

NCT04052061 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: QUILT-3.061
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 study to assess the safety, preliminary efficacy of CD19 t-haNK and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with diffuse large B-cell lymphoma (DLBCL).

Conditions

Diffuse Large B Cell Lymphoma; Large-cell Lymphoma; Lymphoma, B-Cell; Lymphoma

Outcome Measures

Primary Outcomes (3)

• MTD or HTD and RP2D.

  Maximum tolerated dose or highest tested dose and recommended phase 2 dose.

  1 year

• Incidence of DLTs and treatment-emergent adverse events

  Incidence of DLTs and treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  1 year

• Clinically significant changes

  Clinically significant changes in safety laboratory tests, physical examinations, electrocardiograms (ECGs), and vital signs, as determined by the physician and/or lab ranges.

  1 year

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  1 year

• Progression-free Survival (PFS)

  1 year

• Overall Survival (OS)

  1 year

Study Arms (1)

CD19 t-haNK

EXPERIMENTAL

CD19 t-haNK will be administered to patients with Diffuse Large B-Cell Lymphoma who have received 2 or more lines of therapy and are ineligible for transplant.

Biological: CD19 t-haNK

Interventions

CD19 t-haNK BIOLOGICAL

CD19 t-haNK Suspension for Infusion

CD19 t-haNK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
• Have histologically confirmed DLBCL that is refractory or relapsed after at least 2 lines of previous therapy.
• Are ineligible for autologous stem cell transplant, allogeneic stem cell transplant or CAR T cell therapy under 1 of the following conditions:
• Have chemotherapy refractory disease after 2 lines of salvage chemotherapy.
• Have met eligibility for CAR T-cell therapy or transplant, but have refused therapy.
• Have disease progression or relapse within 12 months after autologous or allogeneic stem cell transplant or have relapsed following CAR T-cell therapy and meet the following criteria:
• Had a partial response (PR) or stable disease (SD) at the 3-month disease assessment and then subsequently progressed \> 3 months after first CAR T-cell therapy.
• Have confirmed CD19 tumor expression by biopsy after disease progression and prior to retreatment.
• Have not received subsequent therapy for the treatment of lymphoma post CAR T-cell therapy.
• Toxicities related to conditioning chemotherapy (fludarabine and cyclophosphamide), with the exception of alopecia, have resolved to ≤ grade 1 or returned to baseline prior to retreatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have at least 1 measurable lesion and/or non-measurable disease evaluable in accordance with RECIST Version 1.1.
• Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen obtained following the conclusion of the most recent anticancer treatment and be willing to release the specimen for exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
• Must be willing to provide pre- and post-infusion blood samples for exploratory analyses.

You may not qualify if:

• Body weight at screening of ≤ 50 kg.
• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
• Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
• History of organ transplant requiring immunosuppression.
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Inadequate organ function, evidenced by the following laboratory results:
• Absolute neutrophil count (ANC) \< 750 cells/mm3.
• Platelet count \< 75,000 cells/mm3.
• Hemoglobin \< 9 g/dL.
• Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
• Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases).
• Alkaline phosphatase (ALP) levels \> 2.5 × ULN (\> 5 × ULN in subjects with liver metastases, or \>10 × ULN in subjects with bone metastases).
• Serum creatinine \> 2.0 mg/dL or 177
• Each study site should use its institutional ULN to determine eligibility.
• Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, B-Cell; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 9, 2019
• Study Start: September 16, 2019
• Primary Completion: September 18, 2021
• Study Completion: August 19, 2022
• Last Updated: February 21, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)