ZUMA-2

• Research type

  Research Study

• Full title

  A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) (ZUMA-2)

• IRAS ID

  297093

• Contact name

  Robin Sanderson

• Contact email

  robinsanderson1@nhs.net

• Sponsor organisation

  Kite Pharma, Inc.

• Eudract number

  2015-005008-27

• Clinicaltrials.gov Identifier

  NCT02601313

• Duration of Study in the UK

  17 years, 0 months, 0 days

• Research summary

  The primary objective of this study is to evaluate the efficacy of KTE-X19, as measured by objective response rate (ORR), in subjects with r/r MCL. Secondary objectives will include assessing the safety and tolerability of KTE-X19 and additional efficacy endpoints including duration of response (DOR). Secondary objectives related to Patient-reported outcomes (PROs) in Cohort 3 will include change in EQ-5D and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) scores from baseline over time.

  Total planned recruitment figure for all 3 Cohorts (1,2 and 3) is approximately 220 Patients. Cohorts 1 and 2 are complete and are no longer enrolling; only Cohort 3 is open to enrolment and will enroll approximately 90 patients from approximately 40 sites globally.

  This KTE-C19-102 study is a Phase 2, multicenter, open-label study evaluating the efficacy of KTE-X19 in subjects with r/r MCL. Cohort 3 will enroll and treat up to approximately 90 KTE-X19 subjects with cyclophosphamide and fludarabine conditioning chemotherapy, followed by a target dose of 2 x 106 anti-CD19 CAR T cells per kg body weight.

  The duration of the study will be different for each study participant. Because studies involving genetically engineered cells require long-term follow-up, study participation may last up to 15 years. Visits will occur more frequently in the beginning of the study, but then become less frequent as years go on.

  Each subject will proceed through the following study periods:

  1. Screening
  2. Enrolment/ Leukapheresis
  3. Bridging Therapy, if applicable
  4. Conditioning chemotherapy or Lymphodepleting Chemotherapy
  5. Investigational product (IP) treatment (KTE-X19)
  6. Post-Treatment Assessment period, including collection of:
  a. Blood
  b. Other fluids
  c. Tissue
  d. Bone Marrow
  e. Spinal Fluid
  7. Follow-up
  8. Long Term Follow-up

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  21/LO/0324

• Date of REC Opinion

  3 Jun 2021

• REC opinion

  Further Information Favourable Opinion