UPCC 12420 A Phase 2, Open- Label, Single-Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL)

Investigation of an Investigational Medication for Relapsed or Refractory Slow-Growing B-Cell Non-Hodgkin Lymphoma

UPCC 12420 A Phase 2, Open- Label, Single-Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma (NHL)
Enrolling By Invitation
18 years or above
All
Phase 2
276 participants needed
1 Location

Brief description of study

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

  • Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
  • Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
  • Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphoma, Non-Hodgkin
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
  2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
  3. Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
  4. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate organ function
  7. Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

  1. Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
  2. WHO subclassification of duodenal-type FL
  3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
  4. History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
  5. Prior CAR T-cell or other genetically-modified cell therapy
  6. History of or active human immunodeficiency virus (HIV)
  7. Active hepatitis B or active hepatitis C
  8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
  9. Active autoimmune disease requiring immunosuppressive therapy
  10. Presence of acute or chronic graft-versus-host=disease
  11. History of significant cardiovascular disease
  12. History or presence of clinically relevant central nervous system pathology
  13. Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

This study investigates the efficacy and safety of an investigational medication in adults with relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma (NHL), specifically follicular lymphoma (FL) and marginal zone lymphoma (MZL). The purpose of this study is to understand how well the investigational medication works in treating these types of lymphoma.

Participants will undergo several study procedures, starting with pretreatment assessments including screening and leukapheresis, which is a procedure to collect white blood cells. This is followed by a treatment period where participants receive lymphodepleting chemotherapy and the investigational medication. After treatment, participants will have follow-up assessments to monitor disease status and safety for up to five years.

  • Who can participate: Adults with relapsed or refractory follicular lymphoma or marginal zone lymphoma who have received previous treatments including anti-CD20 and alkylating agents may participate. They must have an ECOG performance status of 0 or 1 and adequate organ function.
  • Study details: Participants will undergo leukapheresis and receive lymphodepleting chemotherapy followed by the investigational medication.
Updated on 28 Jul 2026. Study ID: 20-0546
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