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Clinical Trials in Spain / NCT03960840
Active, not recruiting Phase 1/2

Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

NCT03960840 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2019-06-26
Last updated
2026-06-04

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaDiffuse Large B-cell LymphomaAcute Lymphoblastic LeukemiaLarge B-cell Lymphoma

Investigational drug(s) / intervention(s)

Rapcabtagene autoleucel single agentIbrutinib →

Rapcabtagene autoleucel single agent: Single infusion of rapcabtagene autoleucel

Ibrutinib: Tablets or capsules for oral daily use

Study summary

This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * ECOG performance status 0-1 for ALL and DLBCL * ECOG performance status 0-2 for 1L HR LBCL at screening * CLL or SLL diagnosis according to iwCLL criteria * CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy * DLBCL diagnosis by local histopathology * DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT) * Refractory or relapsed CD19-positive ALL * ALL with morphologic disease in the bone marrow 1L HR LBCL - Considered to be high-risk based on at least 1 of the following at diagnosis: * IPI score of 3, 4 or 5 * MYC and BCL2 and/or BCL6 rearrangement (DH/TH lymphoma) * Participants must have received 2 cycles of frontline therapy for LBCL with R-CHOP or Pola-R-CHP or DA-EPOCH-R. Participants with DH/TH lymphoma must have received at least one cycle (the most recent) DA-EPOCH-R. * Participants must have a positive PET per Lugano classification (Deauville PET score of 4 or 5 and an overall response of PR/SD) after 2 cycles of frontline CIT. Note: Patient's with Deauville PET score of 5 and overall response of PD, or with Deauville PET score of 1, 2, or 3 and overall response of CR, are not eligible for this trial. Exclusion Criteria: * Prior CD19-directed therapy * Prior administration of a genetically engineered cellular product * Prior allogeneic HSCT * Richter's transformation * For 1L HR LBCL: Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, DLBCL associated with chronic inflammation, intravascular large B-cell lymphoma, ALK- positive large B-cell lymphoma, HHV8 positive LBCL, DLBCL leg type or EBV positive DLBCL, NOS. * Active CNS lymphoma * For 1L HR LBCL: Active or prior history CNS involvement by malignancy * Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis Other protocol-defined inclusion/exclusion may apply.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
University of California LA Los Angeles California
Stanford University Medical Center Stanford California
H Lee Moffitt Cancer Center and Research Institute Tampa Florida
Uni of Chi Medi Ctr Hema and Onco Chicago Illinois
University of Kansas Cancer Center Westwood Kansas
Mass Gen Hosp Cancer Center Boston Massachusetts
University of Pennsylvania Clinical Philadelphia Pennsylvania
Tennessee Oncology Nashville Tennessee
Sarah Cannon Research Institute Nashville Tennessee
St Davids South Austin Medical Ctr Austin Texas
Uni Of TX MD Anderson Cancer Cntr Houston Texas
Medical College of Wisconsin Milwaukee Wisconsin
Novartis Investigative Site Melbourne Victoria
Novartis Investigative Site Melbourne Victoria
Novartis Investigative Site Vienna Austria
Novartis Investigative Site Marseille France
Novartis Investigative Site Paris France
Novartis Investigative Site Pierre-Bénite France
Novartis Investigative Site Rennes France
Novartis Investigative Site Frankfurt am Main Hesse
Novartis Investigative Site Leipzig Saxony
Novartis Investigative Site Bergamo BG
Novartis Investigative Site Milan MI
Novartis Investigative Site Rozzano MI
Novartis Investigative Site Sapporo Hokkaido
Novartis Investigative Site Bunkyo Ku Tokyo
Novartis Investigative Site Fukuoka Japan
Novartis Investigative Site Badalona Barcelona
Novartis Investigative Site L'Hospitalet de Llobregat Barcelona
Novartis Investigative Site Barcelona Spain
Novartis Investigative Site Barcelona Spain
Novartis Investigative Site Córdoba Spain
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Salamanca Spain
Novartis Investigative Site Seville Spain
Novartis Investigative Site Valencia Spain

On this site

📄 Imbruvica (ibrutinib) drug profile →

More Novartis Pharmaceuticals trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03960840 on ClinicalTrials.gov ↗ ← All trials in Spain