CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520) | Clinical Trial Compass
RecruitingPhase 1/2
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
United States100 participantsStarted 2020-05-18
Plain-language summary
This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients must be aged ≥18 years and ≤80 years with relapsed or refractory B-cell non-Hodgkin Lymphoma.
✓. Absolute cluster of differentiation 3 (CD3) count ≥50 mm\^3.
✓. Magnetic resonance imaging (MRI) brain and lumbar puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment EXCEPT Arm E subjects.
✓. Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL (see separate criteria for CLL and primary/secondary CNS lymphoma).
✓. Karnofsky performance score ≥70.
✓. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \<5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.
✓. ANC≥1000 with no G-CSF within 72 hours or pegylated G-CSF within 14 days.
✓. Platelets≥50,000 with no transfusion within 72 hours.
Exclusion criteria
✕. Positive beta- human chorionic gonadotropin (HCG) in female of childbearing potential.
What they're measuring
1
Number of Adverse Events after CAR 20/19-T cell infusion
Timeframe: Within the first 28 days after infusion
Trial details
NCT IDNCT04186520
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-02-28
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office
. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
✕. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \>20 mg of prednisone or equivalent daily.
✕. Presence of ≥grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.
✕. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.
✕. Refusal to participate in the long-term follow-up protocol
✕. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture (Not applicable to Arm E cohort.)
✕. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \<100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.