WithdrawnPhase 1/2

QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL

Stopped: Trial not initiated

0Started 2017-12

Plain-language summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with with CD20-positive NHL who have progressed on or after rituximab therapy.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years.
✓. Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
✓. Histologically confirmed relapsed CD20-positive NHL with progression on or within 6 months after rituximab therapy.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Have at least 1 measurable lesion of ≥ 1.5 cm.
✓. Must have a recent tumor biopsy specimen obtained following the conclusion of the most recent anti-cancer treatment. If a historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
✓. Must be willing to provide blood samples, and, if considered safe by the Investigator, a tumor biopsy specimen at 8 weeks after the start of treatment.
✓. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.

Exclusion criteria

✕. History of persistent grade 2 or higher (CTCAE Version 4.03) hematologic toxicity resulting from previous therapy.
✕. Within 5 years prior to first dose of study treatment, any evidence of other active malignancies or brain metastasis except controlled basal cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, cervical); prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy) and with undetectable prostate-specific antigen (PSA) (\< 0.2 ng/mL).
✕. 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).
✕. Requires whole blood transfusion to meet eligibility criteria.
✕. Inadequate organ function, evidenced by the following laboratory results:

What they're measuring

Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

Timeframe: 1 year

Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Timeframe: 1 year

ORR by Immune-related response criteria (irRC )

Timeframe: 1 year

Trial details

NCT IDNCT03169790

SponsorImmunityBio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Non Hodgkin Lymphoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years.
✓. Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
✓. Histologically confirmed relapsed CD20-positive NHL with progression on or within 6 months after rituximab therapy.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Have at least 1 measurable lesion of ≥ 1.5 cm.
✓. Must have a recent tumor biopsy specimen obtained following the conclusion of the most recent anti-cancer treatment. If a historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
✓. Must be willing to provide blood samples, and, if considered safe by the Investigator, a tumor biopsy specimen at 8 weeks after the start of treatment.
✓. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.

Exclusion criteria

✕. History of persistent grade 2 or higher (CTCAE Version 4.03) hematologic toxicity resulting from previous therapy.
✕. Within 5 years prior to first dose of study treatment, any evidence of other active malignancies or brain metastasis except controlled basal cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, cervical); prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy) and with undetectable prostate-specific antigen (PSA) (\< 0.2 ng/mL).
✕. 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).
✕. Requires whole blood transfusion to meet eligibility criteria.
✕. Inadequate organ function, evidenced by the following laboratory results:

What they're measuring

Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

Timeframe: 1 year

Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Timeframe: 1 year

ORR by Immune-related response criteria (irRC )

Timeframe: 1 year