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QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

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

Open-Label, Phase 1 Study of CD19 t-haNK In Subjects With Diffuse Large B-Cell Lymphoma Who Have Received 2 Or More Lines of Therapy And Are Ineligible For Transplant

NCT04052061•ImmunityBio, Inc.

View on ClinicalTrials.gov

Summary

Detailed Description

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). The study will be conducted in 2 parts: part 1 will involve dose escalation and part 2 will involve expansion of the recommended phase 2 dose.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years old.
•2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
•3. Have histologically confirmed DLBCL that is refractory or relapsed after at least 2 lines of previous therapy.
•4. Are ineligible for autologous stem cell transplant, allogeneic stem cell transplant or CAR T cell therapy under 1 of the following conditions:
•1. Have chemotherapy refractory disease after 2 lines of salvage chemotherapy.
•2. Have met eligibility for CAR T-cell therapy or transplant, but have refused therapy.
•5. 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:
•1. 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.
•2. Have confirmed CD19 tumor expression by biopsy after disease progression and prior to retreatment.
•3. Have not received subsequent therapy for the treatment of lymphoma post CAR T-cell therapy.
+7 more criteria

Exclusion Criteria

•1. Body weight at screening of ≤ 50 kg.
•2. 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.
•3. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
•4. History of organ transplant requiring immunosuppression.
•5. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
•6. Inadequate organ function, evidenced by the following laboratory results:
•1. Absolute neutrophil count (ANC) \< 750 cells/mm3.
•2. Platelet count \< 75,000 cells/mm3.
•3. Hemoglobin \< 9 g/dL.
•4. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
+13 more criteria

Locations (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, United States

Key Dates

Start Date

September 16, 2019

Primary Completion Date

September 18, 2021

Completion Date

August 19, 2022

Last Updated

February 21, 2025

Conditions

Diffuse Large B Cell LymphomaLarge-cell LymphomaLymphoma, B-CellLymphoma

Interventions

CD19 t-haNK

BIOLOGICAL

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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RECRUITINGPHASE1

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL