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Diffuse Large B Cell LymphomaPhase 1NCT04052061

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

A Phase 1 study testing CD19 t-haNK in people with Diffuse Large B Cell Lymphoma and Large-cell Lymphoma, run by ImmunityBio, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CD19 t-haNK
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
16 Sep 2019to 19 Aug 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 5 months after the last dose of CD19 t-haNK for Infusion. Non-sterile male subjects must agree to use a condom while on study and for up to 5 months after the last dose of CD19 t-haNK for Infusion. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.

Who cannot join

  • 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:
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  • 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.
  • Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  • Positive results of screening test for human immunodeficiency virus (HIV).
  • Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  • Known hypersensitivity to any component of the study medication(s).
  • Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to dosing for this study, except for testosterone-lowering therapy in men with prostate cancer.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women. A negative serum pregnancy test during screening and a negative pregnancy test within 72 hours prior to the first dose must be documented before CD19 t haNK for Infusion is administered to a female subject of child-bearing potential.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

Other trials in United States

About this study

Official title: 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

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).

Read the 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.

Being tested
CD19 t-haNK
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Dendritic Cell Sarcoma, Interdigitating, Lymphoma, B-Cell, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19 t-haNKBiological

    CD19 t-haNK Suspension for Infusion

Study groups in NCT04052061
Study groupRoleWhat they receive
CD19 t-haNKExperimentalCD19 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.
Receives: Biological: CD19 t-haNK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD or HTD and RP2D.

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

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    ORR in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and modified RECIST guidelines for immunotherapy trials (iRECIST).

    Measured: 1 year

  2. Progression-free Survival (PFS)

    Progression-free Survival (PFS) by RECIST Version 1.1 and iRECIST.

    Measured: 1 year

  3. Overall Survival (OS)

    OS will be evaluated using Kaplan-Meier methods.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2019
  2. Study start16 Sep 2019 (estimated)
  3. Primary completion18 Sep 2021 (estimated)
  4. Study completion19 Aug 2022

Why it stopped: Trial not initiated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04052061
Sponsor's protocol ID
QUILT-3.061
Status last verified
May 2022
First submitted
7 Aug 2019
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19 t-haNK in people with Diffuse Large B Cell Lymphoma and Large-cell Lymphoma, run by ImmunityBio, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD or HTD and RP2D. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04052061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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