Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04240808
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated Informed Consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the parent study and the long-term follow-up observational study.
* Male or non-pregnant, non-lactating females, aged 18 to 80 years.
* Performance status according to the Eastern Cooperative Oncology Group ≤ 2.
* Failed two or more lines of systemic therapy.
* Unable to receive commercially available CD19 CAR T Cells.
* Relapsed or primary refractory CD19 positive (i.e. CD19 expressing) B-NHL of the following types as confirmed by either flow cytometry, Immunohistochemistry (IHC), or both:
* Diffuse large B-cell lymphoma (DLBCL)
* Burkitt lymphoma
* Intermediate lymphoma between Burkitt and DLBCL
* Primary Mediastinal B-cell lymphoma (PMBL)
* Follicular lymphoma
* Mantle cell lymphoma (MCL)
* Marginal zone lymphoma (MZL)
* No available curative alternative treatment, as determined by primary treating oncologist.
* No active Graft-versus-Host Disease (GvHD).
* In women of childbearing potential, willingness to use effective means of birth control for 1 year after UCD19 CAR T Cell infusion.
Exclusion Criteria:
* Prior therapies:
* Received monoclonal antibody therapy within 14 days of the apheresis; or
* Received immunomodulatory drugs (lenalidomide, tyrosine kinase inhibitors) within 14 days of the apheresis; or
* Received corticosteroids more than 7.5mg/day within 14 days of the apheresis (physiologic replacement allowed up until apheresis, as clinically indicated); or
* Allogeneic hematopoietic stem cell transplant with 90 days (immunosuppressive therapy for at least 4 weeks) of apheresis; or
* Donor lymphocyte infusion within 4 weeks of apheresis.
* Cluster of differentiation 3 (CD3) count \<0.15 x 106 cells/mL
* Severe psychiatric illness that could impede the patient's ability to provide informed consent and/or adhere to the parent protocol and/or the long-term follow-up protocol.
* Active HIV (Acquired Immune Deficiency Syndrome) or history of HIV infection, as directed by schedule or if known.
* Active Hepatitis B or Hepatitis C infection.
* Diffusion capacity of the lungs for carbon monoxide \< 40% predicted prior to lymphodepletion.
* Left ventricular ejection fraction \< 40% (evaluated by echocardiogram \[ECHO\] or Multigated Acquisition Scan \[MUGA\]) prior to lymphodepletion.
* Transaminases \> 5x upper limit of normal prior to lymphodepletion.
* Serum Bilirubin \> 4 mg/dL prior to lymphodepletion.
* Serum Creatinine \> 1.6 mg/dL or measured creatinine clearance \< 50 mL/min prior to lymphodepletion.
* Active infection that is unresponsive to antimicrobial therapy prior to lymphodepletion.
* Females planning to become pregnant during the course of the study.
* Unwillingness or inability to comply with study visits and study procedures for the entire duration of study participation.
* Unsuitable for cellular therapy for any reason, in the opinion of the Investigator.
* Any prior gene therapy, including prior CAR T cell therapy.
* Active central nervous system (CNS) disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04240808
Study Brief:
Protocol Section:
NCT04240808