Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Conditions

• Refractory Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• KTE-C19 — BIOLOGICAL
  A single infusion of KTE-C19 CAR-T cells administered intravenously
• Atezolizumab — BIOLOGICAL
  Administered intravenously
• Cyclophosphamide — DRUG
  Administered intravenously
• Fludarabine — DRUG
  Administered intravenously

Study Details

The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL). Participants who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309).

Key Dates

First listed

Oct 6, 2016

Start date

Sep 29, 2016

Status verified

Feb 2024

Primary completion

Jan 12, 2023

Completion

Jan 12, 2023

Study Design

Enrollment

37 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1 Cohort 1: KTE-C19 + ATZ (After 21 Days of KTE-C19)
  Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide intravenous (IV) infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg followed by 4 doses of atezolizumab (ATZ) (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.
• Experimental: Phase 1 Cohort 2: KTE-C19 + ATZ (After 14 Days of KTE-C19)
  Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.
• Experimental: Phase 1 Cohort 3: KTE-C19 + ATZ (After 1 Day of KTE-C19)
  Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
• Experimental: Phase 2: KTE-C19 + ATZ (After 1 Day of KTE-C19)
  Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.

Primary Outcome Measure

Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Baseline up to 21 days ]

Locations (5)

Find similar trials in Duarte, CA