Phase I/II study of rapcabtagene autoleucel in CLL, 3L+ DLBCL, ALL and 1L HR LBCL

JRCT ID: jRCT2013210066

Registered date:31/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: DLBCL, ALL, CLL
• Date of first enrollment: 18/01/2022
• Target sample size: 11
• Countries of recruitment: United States,Japan,Australia,Japan,Austria,Japan,France,Japan,Italy,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

DLBCL, ALL : Single infusion of YTB323
CLL : Single infusion of YTB323 and daily ibrutinib

Outcome(s)

Primary Outcome

1. Dose recommendation: incidence and nature of Dose Limiting Toxicities (Dose Escalation part only) [ Time Frame: 24 months ]
2. Safety: incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs [ Time Frame: 24 months ]
3. Tolerability: ibrutinib dose modifications in the CLL/SLL arm [ Time Frame: 24 months ]
4. Manufacture success: number of patients infused with planned target dose [ Time Frame: 24 months ]
5. Phase 2: Complete Response Rate (CRR) as assessed by local Investigator [ Time Frame: 24 months ]
CRR defined as best overall response (BOR) of CR after rapcabtagene autoleucel infusion as per Lugano criteria for 3L+ Diffuse Large B-Cell Lymphoma (DLBCL) and 1L High Risk Large B-Cell (HR LBCL)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- ECOG performance status 0-1
- 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/THL)

Exclude criteria

- Prior CD19-directed therapy
- Prior administration of a genetically engineered cellular product
- Prior allogeneic HSCT
- Richter's transformation
- Active CNS lymphoma
- Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT03960840