Study of ET190L1 ARTEMIS™ T Cells in Relapsed and Refractory CD19+ Non-Hodgkin's Lymphoma

Stopped early · Phase 1

Conditions studied: Lymphomas Non-Hodgkin's B-Cell

In brief

This is a non-randomized, single arm, open-label, single institution, phase I study to determine the maximum tolerated dose (MTD) of ET190L1 ARTEMIS™ T cells in patients ≥ 18 years of age with relapsed or refractory CD19+ Non-Hodgkin's lymphoma.

Key facts

Study ID

NCT03379493

Run by

Eureka Therapeutics Inc.

People needed

4

Starts

2018-04-04

Expected to finish

2019-01-30

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with relapsed/refractory CD19+ Non-Hodgkin's lymphoma of the following subtypes:
• Diffuse large B-cell lymphoma (DLBCL)
• Mantle cell lymphoma (MCL)
• Follicular lymphoma (FL)
• Chronic lymphocytic leukemia and Small lymphocytic lymphoma (CLL/SLL)
• Burkitt's Lymphoma
• Ability to provide written informed consent for the protocol.
• Willingness and ability to comply with scheduled visit, treatment plans, laboratory tests, and other procedures.
• Age ≥ 18 years old.
• Eastern Cooperative Oncology Group performance status of ≤ 2.
• Evidence of at least one measurable lesion (nodes/nodal masses > 1.5 cm, extranodal masses >1.0 cm or PET avid lesions consistent with lymphoma) on imaging with the following exceptions:
• Patients treated with interim chemotherapy for disease control between enrollment and ET190L1 ARTEMIS™ T cell infusion who do not have measurable disease at re-screening are still eligible.
• CLL/SLL with documented B-cell absolute lymphocytosis > 5 x 109 cells/L peripheral blood or infiltration of lymph nodes and/or bone marrow infiltration by CLL phenotype cells defined as: clonal B cells with majority population co-expressing CD5 and CD19, with surface immunoglobulin (sIg, kappa or lambda but not both) and CD20 (dim), CD23+ (if CD20 or sIg are bright or if CD23 is dim or negative [atypical CLL phenotype] then FISH for 11:14 translocation must be performed to differentiate from mantle cell lymphoma).
• Lesions previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
• Must have biopsy-proven primary refractory disease or relapsed disease after front-line chemo-immunotherapy (with anti-CD20 mAb in combination with anthracycline-based chemotherapy) or at least one of the following:
• For subjects with DLBCL: relapsed or refractory disease after ≥ 2 prior line(s) of therapy. For both de novo and transformed disease, patients must have received at least 1 prior regimen with anti-CD20 mAb and anthracycline.
• For subjects with FL or SLL: relapsed or refractory disease after ≥ 2 prior line(s) of therapy.
• For subjects with CLL: must be relapsed or refractory disease and:
• with no unfavorable cytogenetics and have failed ≥ 3 prior line(s) of therapy.
• with unfavorable cytogenetics including del17p/mutated p53 or unmutated immunoglobulin heavy chain variable region relapsed or refractory disease after ≥ 2 prior line(s) of therapy which must have included ibrutinib.
• For subjects with MCL: relapsed or refractory disease after at least 1 prior regimen with chemoimmunotherapy.
• For subjects with Burkitt's: relapsed or refractory disease after at least 1 prior line of therapy.
• Any patient, with subtypes listed above, having either failed autologous HSCT after at least 1 prior regimen, or those patients ineligible for, but not an appropriate candidate, or not consenting to autologous HSCT.
• Adequate organ function parameters are set according to what the treating physician defines as adequate organ function and are acceptable for participation in this trial. These criteria are defined as:
• Renal function:

You may not qualify if…

• Prior Treatment:
• With any prior anti-CD19/anti-CD19 CAR-T or cellular therapy (prior Blinotumomab therapy is allowed)
• Treatment with any prior gene therapy
• Prior allogeneic hematopoietic stem cell transplant
• Received chemotherapy, radiation or surgical resection of malignancy within 2 weeks prior to the start of conditioning chemotherapy (day -10 to -5).
• Active, uncontrolled serious infection or medical or psychiatric illness, that in the investigator's opinion is likely to interfere with participation in this clinical trial
• Active CNS involvement by malignancy.
• History of seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
• Active replication of hepatitis B or active hepatitis C (HCV RNA positive). Those with prior disease who are PCR negative at enrollment and meet liver function eligibility criterion are eligible.
• Known HIV positive patients
• Patients with unstable angina and/or myocardial infarction within 6 months prior to screening.
• Cardiac arrhythmia not controlled with medical management, evidence of pericardial effusion on imaging that is compromising function.
• Previous or concurrent malignancy with exception of adequately treated basal cell or squamous cell carcinoma, in-situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to study drug infusion, or prostate cancer that was treated with prostatectomy or radiotherapy over 2 years before day 1 of protocol therapy and patients whose PSA is undetectable at study entry.
• Autoimmune disease or history of primary immunodeficiency (excluding Hashimoto's thyroiditis, vitiligo, or DM type I)
• Women who are pregnant or breast feeding.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.