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

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)

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