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Rapcabtagene autoleucel single agent

Phase 1

Chronic Lymphocytic Leukemia | Monoclonal antibody | Oncology |Novartis AG|Last Updated: Jun 4, 2026

Success Probability

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment217

FDA Designations

No designations recorded

Clinical trial landscape

Rapcabtagene autoleucel single agent · 1 trial · 5 indications

Phase 1 1
NCT03960840Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCLChronic Lymphocytic Leukemia
ACTIVE NOT_RECRUITING217 Analytics
PHASE1ACTIVE NOT_RECRUITING
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
Chronic Lymphocytic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1: Dose recommendation: Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only)
28 days
Phase 1: Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs
24 months
Phase 1: Tolerability: Ibrutinib dose modifications in the CLL/SLL arm
24 months
Phase 1: Manufacture success: Number of patients infused with planned target dose
24 months
Phase 2: Complete Response Rate (CRR) as assessed by local Investigator
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)

Secondary Endpoints

Phase 1: Complete Response (CR)/Partial Response (CR) in CLL/SLL
24 months
Phase 1: BOR of CR/PR per Lugano criteria in 3L+ DLBCL
24 months
Phase 1: Duration of response (DOR) in CLL/SLL and 3L+ DLBCL
24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CLL/SLLEXPERIMENTALDose escalation of rapcabtagene autoleucel in combination with ibrutinib
3L+ DLBCLEXPERIMENTALDose escalation and expansion of rapcabtagene autoleucel single agent in 3L+ DLBCL
Adult ALLEXPERIMENTALDose escalation of rapcabtagene autoleucel single agent in adult ALL
1L HR LBCLEXPERIMENTALRapcabtagene autoleucel single agent in 1L HR LBCL

Interventions

NameTypeDescription
Rapcabtagene autoleucel single agentBIOLOGICALSingle infusion of rapcabtagene autoleucel
IbrutinibDRUGTablets or capsules for oral daily use
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites37

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 diagnos...

Countries:United StatesAustraliaAustriaFranceGermanyItalyJapanSpain
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Frequently asked questions about Rapcabtagene autoleucel single agent

What is Rapcabtagene autoleucel used for?

Rapcabtagene autoleucel is an investigational cell therapy being studied for the treatment of chronic lymphocytic leukemia (CLL). It is also being evaluated in other blood cancers, including small lymphocytic lymphoma, diffuse large B-cell lymphoma, acute lymphoblastic leukemia, and large B-cell lymphoma, as part of an ongoing clinical trial.

Who is developing Rapcabtagene autoleucel?

Rapcabtagene autoleucel is being developed by Novartis AG, a global healthcare company. Novartis is listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development for chronic lymphocytic leukemia and other hematologic malignancies.

What phase is Rapcabtagene autoleucel in?

Rapcabtagene autoleucel is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1/II study is currently active but not recruiting participants, and it is being conducted across multiple countries.

What clinical trials is Rapcabtagene autoleucel in?

Rapcabtagene autoleucel is being studied in a Phase 1/II clinical trial with the identifier NCT03960840. This trial is evaluating the drug in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, diffuse large B-cell lymphoma, acute lymphoblastic leukemia, and large B-cell lymphoma. The trial is active but not recruiting.

How does Rapcabtagene autoleucel work?

Rapcabtagene autoleucel is a cell therapy, as indicated by its '-cel' suffix, which denotes a cellular treatment. It is being developed as a single agent for chronic lymphocytic leukemia. The specific molecular target of this therapy has not been disclosed in the available information.

Is Rapcabtagene autoleucel the same as other CAR-T therapies?

Rapcabtagene autoleucel is a distinct investigational cell therapy developed by Novartis. It is being studied specifically for chronic lymphocytic leukemia and other blood cancers. No alternative names for this drug have been reported, and it is not known to be identical to any other approved or investigational therapy.