Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL (NCT03960840) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
United States, Australia, Austria217 participantsStarted 2019-06-26
Plain-language 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).
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 transfor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is Phase I/II, which means it's still partly focused on figuring out safe doses and understanding side effects — given that, what does my doctor think is currently known about the safety profile of rapcabtagene autoleucel, and how does that uncertainty compare to CAR-T therapies that are already approved?
2The trial is listed as 'active, not recruiting,' which means I likely can't enroll right now — but are there plans to open enrollment again, or are there similar CAR-T studies I should be looking into instead?
3I noticed the CLL/SLL arm of this trial involves ibrutinib alongside the CAR-T therapy, and one thing being measured is how often ibrutinib doses need to be changed — what does that tell us about how complex this treatment combination might be to manage, and would that work with my current medications or health situation?
4For the Phase 2 part, the main thing being measured is Complete Response Rate — can my doctor explain what 'complete response' means for my specific diagnosis, and how the response rates seen so far in this trial compare to what I might expect from standard treatment options?
5Since this trial covers several different blood cancers and treatment lines, including some patients on their third or later line of therapy, can my doctor help me understand whether my situation would have been a match for this study and what that tells us about which treatments might still be worth pursuing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Dose recommendation: Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only)
Timeframe: 28 days
2
Phase 1: Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs
Timeframe: 24 months
3
Phase 1: Tolerability: Ibrutinib dose modifications in the CLL/SLL arm
Timeframe: 24 months
4
Phase 1: Manufacture success: Number of patients infused with planned target dose
Timeframe: 24 months
5
Phase 2: Complete Response Rate (CRR) as assessed by local Investigator