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Study of Rapcabtagene autoleucel (YTB323) in adult patients with CLL/SLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
EU CTIS ID: 2023-507062-34-00
What this study is testing
Phase I: The primary objective of the Phase I part of this study is to identify the Recommended Dose of rapcabtagene autoleucel and to characterize safety of rapcabtagene autoleucel as single agent in r/r DLBCL and r/r adult ALL, and to characterize the safety of rapcabtagene autoleucel in combination with ibrutinib in CLL/SLL. Another primary objective is to evaluate the feasibility of rapcabtagene autoleucel manufacturing process. Phase II: 3L+ DLBCL: The primary objective is to demonstrate the antitumor activity of rapcabtagene autoleucel on complete disease response as assessed by local Investigator. 1L HR LBCL: The primary objective is to assess the antitumor activity of rapcabtagene autoleucel on complete disease response as assessed by local Investigator.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 3L+ DLBCL: Relapsed or refractory disease having received 2 or more lines of therapy, including anti-CD20 and anthracycline-based chemotherapy, and either having progressed (or relapsed) after autologous HSCT or being ineligible/not consenting to the procedure. Measurable disease at time of enrollment.
- ALL: r/r CD19-positive ALL with morphologic disease in the bone marrow (≥ 5% blasts) and including at least 1 of the following: • After allogeneic HSCT • After 2 or more lines of treatment • Primary refractory disease • First relapse occurring within 12 months from first remission • Patients with Philadelphia chromosome-positive ALL must have failed at least 2 different tyrosine kinase inhibitors.
- 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).
- 1L HR LBCL: - 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 DA-EPOCH-R.
- 1L HR LBCL: - 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.
You likely can't join if
- ALL: allogeneic HSCT within 12 weeks prior to screening
- Prior CD19-directed therapy with the exception of blinatumomab for patients with ALL
- Prior administration of a genetically modified cellular product
- 3L+ DLBCL with primary CNS lymphoma
- 3L+ DLBCL: prior allogeneic HSCT
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.