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Drug

Ciltacabtagene autoleucel

Approved medicine
ClassTumor necrosis factor receptor superfamily member 17 binding agentResearchOngoing clinical research

Also known as Autologous bi-epitope BCMA-targeted CAR T-cells, Carvykti, Cilta-cel, Ciltacel.

RxNorm2594775ChEMBLCHEMBL4802263ATCL01XL05UNII0L1F17908Q
11
Active clinical trials
TNFRSF17
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

Clinical trial2026-07-06Results expected Q2 2028 · ClinicalTrials.gov

A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Clinical trial2026-07-06Results expected Q3 2027 · ClinicalTrials.gov

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Clinical trial2026-07-06Results expected Q3 2030 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Clinical trial2026-07-06Results expected Q1 2029 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Clinical trial2026-07-06Results expected Q3 2037 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Clinical trial2026-03-17Results expected Q2 2033 · ClinicalTrials.gov

A Pilot Safety and Feasibility Study of Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function

Clinical trial2026-03-11Results expected Q2 2027 · ClinicalTrials.gov

DART: Phase II Study of Dasatinib and Quercetin in Patients With Relapsed, Refractory Multiple Myeloma Receiving CAR-T Therapy

Clinical trial2026-02-06Results expected Q3 2031 · ClinicalTrials.gov

Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma

Clinical trial2026-01-05Results expected Q3 2027 · ClinicalTrials.gov

CAR- PRISM (PRecision Intervention Smoldering Myeloma): A Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in High-Risk Smoldering Myeloma

Clinical trial2025-12-15Primary completion · ClinicalTrials.gov

Approval: Carvykti (EMA)

Regulatory2022-05-25EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ciltacabtagene autoleucel
Aliases & brands
Autologous bi-epitope BCMA-targeted CAR T-cellsCarvyktiCilta-celCiltacel
RxNorm CUI
2594775
ChEMBL ID
CHEMBL4802263
ATC codes
L01XL05
UNII
0L1F17908Q
Primary mechanism
Tumor necrosis factor receptor superfamily member 17 binding agent
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tumor necrosis factor receptor superfamily member 17
TNFRSF17 · Q02223
BINDING AGENTTumor necrosis factor receptor superfamily member 17 binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-05-25
Latest approval
2022-05-25
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-05-25Approval
Approval: Carvykti (EMA)
Indication: Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an… Show full indication

Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

12 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
12
registered trials across all phases
LATEST COMPLETION 2023
11
Active studies
5
Recruiting
4
Late-stage (III+)
1
Completed
PHASE DISTRIBUTIONn = 12
Phase 12Phase 26Phase 33Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

RecruitingPH IVJanssen Research & Development, LLCn=2952042

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Active, not recruitingPH IIIStichting European Myeloma Networkn=7592040

A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Active, not recruitingPH IIIJanssen Research & Development, LLCn=7432036

A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

Active, not recruitingPH IIIJanssen Research & Development, LLCn=4192027

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma

CompletedPH IIJanssen Scientific Affairs, LLCn=862023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.