A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma - KT-US-499-0150 (ICON 0035/0353)

Kite Pharma, Inc.0 sites7 target enrollmentTBD

Conditionslymph node cancer non-Hodgkin's B-cell lymphoma 10025320

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: lymph node cancer
Sponsor: Kite Pharma, Inc.
Enrollment: 7
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Kite Pharma, Inc.

Eligibility Criteria

Inclusion Criteria

•1\) Subjects with any of the following B\-cell lymphomas as defined by the WHO 2016 criteria, as determined by the investigator, are eligible for the study as defined below: a) Histologically confirmed r/r LBCL (including all subtypes in WHO 2016 as well as transformed iNHL) and r/r FL Grade 3b with r/r disease after at least 2 lines of systemic therapy that can include auto\-SCT. Or subjects with chemorefractory disease to first\-line therapy (primary refractory disease) by satisfying any of the following criteria: \- Progressive disease (PD) as the best response to first\-line therapy \- Stable disease (SD) as the best response after at least 4 cycles of first\-line therapy (eg, 4 cycles of R\-CHOP) with a SD duration of no longer than 6 months from the last dose of therapy \- Partial response (PR) as best response after at least 6 cycles of first\-line therapy (eg, 6 cycles of R\-CHOP) i) Prior therapy must have included an anti\-CD20 mAb and an anthracycline\-containing chemotherapy regimen. ii) Subjects with transformed iNHL are eligible if r/r after 1 line of therapy to account for prior therapy given before transformation if they received at least 1 line of therapy prior to transformation. b) Histologically confirmed iNHL (including the subtypes below), with r/r disease after at least 2 lines of therapy. SD (without relapse) \> 1 year from completion of the last therapy is not eligible. SD (without relapse) \< 1 year from completion of therapy is eligible. i) Subtypes include the following: (1\) Grade 1, 2, or 3a FL (2\) Nodal, extranodal, or splenic MZL ii) Prior therapy must have included an anti\-CD20 mAb combined with an alkylating agent c) Histologically confirmed NLPHL with r/r disease after at least 2 lines of systemic chemotherapy d) Histologically confirmed B\-cell lymphoma, unclassifiable (with features intermediate between DLBCL and cHL) with r/r disease after at least 2 lines of systemic chemotherapy 2\) At least 1 measurable lesion according to the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph\-node disease, at least 1 lymph node should be \>\= 1\.5 cm. 3\) The following washout periods must be satisfied: a) At least 2 weeks or 5 half\-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy and anti\-CD20 mAb therapy. b) At least 3 half\-lives must have elapsed after any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, and 4\-1BB agonists). c) At least 28 days must have elapsed since any prior anti\-CD20 mAb therapy before the KITE\-363 infusion. d) At least 4 weeks must have elapsed after any prior immunosuppression therapy before the KITE\-363 infusion. Note: This criterion does not apply to subjects who receive bridging Please refer to Table 5 for list of allowed bridging therapy agents. 4\) Prior anti\-CD19 and anti\-CD20 targeted therapies are allowed if administered at least 28 days (if monoclonal antibody) or 3 months (if CAR T\-cell product) before the KITE\-363 infusion. CD19 and/or CD20 expression must be confirmed, as p

Exclusion Criteria

•1\) Grade 4 CRS or Grade 4 neurologic toxicity attributed to prior treatment
•with a CAR T\-cell therapy or other genetically modified T\-cell therapy
•targeting CD19 and/or CD20
•2\) History of malignancy other than nonmelanoma skin cancer or carcinoma in
•situ (eg, cervix, bladder, or breast) unless the subject has been disease free
•and without anticancer therapy for at least 3 years. Subjects with asymptomatic
•localized low\-grade prostate cancer for which a watch\-and\-wait approach is
•standard of care are eligible.
•3\) History of Richter\*s transformation of chronic leukemic lymphoma, small
•lymphocytic lymphoma, or lymphoplasmacytic lymphoma