Clinical trial · Interventional
Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma
A Phase 1 Multicenter Study of KITE-585, an Autologous Anti-BCMA CAR T-Cell Therapy, in Subjects With Relapsed/Refractory Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to lack of efficacy
Summary
Brief summary (as posted)
The primary objective of the study is to evaluate the safety and tolerability of KITE-585, an autologous engineered chimeric antigen receptor (CAR) T-cell product targeting a protein commonly found on myeloma cells called B-cell maturation antigen (BCMA), as measured by the incidence of dose-limiting toxicities (DLTs). Participants will be given a 3 day course of conditioning chemotherapy followed by a single infusion of KITE-585.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| KITE-585 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose Escalation: 3 x 10^7 KITE-585
- description
- Participants with relapsed/refractory multiple myeloma (RRMM), will receive conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day intravenous (IV) infusion for 3 days followed by a single infusion of KITE-585 at a dose of 3 x 10\^7 autologous anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells on Day 0. Participants may also receive an optional bridging therapy at the investigator's discretion, up to 7 days before initiation of conditioning chemotherapy. Participants will then have a post-treatment assessment period and long-term follow-up period from Week 2 to Month 3 and after Month 3 to Year 15, respectively.
- interventionNames
- Genetic: KITE-585
- Drug: Cyclophosphamide
- Drug: Fludarabine
- type
- EXPERIMENTAL
- label
- Dose Escalation: 1 x 10^8 KITE-585
- description
- Participants with RRMM, will receive conditioning chemotherapy consisting of cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day IV infusion for 3 days followed by a single infusion of KITE-585 at a dose of 1 x 10\^8 autologous anti-BCMA CAR T cells on Day 0. Participants may also receive an optional bridging therapy at the investigator's discretion, up to 7 days before initiation of conditioning chemotherapy. Participants will then have a post-treatment assessment period and long-term follow-up period from Week 2 to Month 3 and after Month 3 to Year 15, respectively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Measurable relapsed or refractory myeloma as defined by the International Myeloma Working Group (IMWG) Consensus Criteria following treatment with at least 3 lines of therapy including with both a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or progressive myeloma that is refractory to a regimen containing both a PI and an IMiD. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: * Absolute neutrophil count (ANC) ≥ 1,000/µL * Platelet count ≥ 75,000/µL * Absolute lymphocyte count ≥ 100/µL * Creatinine clearance above limits set in the protocol for each cohort * Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram * Baseline oxygen saturation \> 92% on room air and no clinically significant pleural effusion Key Exclusion Criteria: 1. Plasma cell leukemia 2. Non-secretory multiple myeloma 3. History of Central nervous system (CNS) involvement by multiple myeloma 4. Prior CAR therapy or other genetically modified T cells 5. Inadequate washout from prior therapy 6. Autologous stem cell transplant within 6 weeks before enrollment or any history of allogenic transplant 7. History of active autoimmune disease 8. History of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment 9. Recent history of other (non multiple myeloma) cancer 10. Active viral, fungal, bacterial or other infection Note: Other protocol defined Inclusion/Exclusion criteria may apply
References
Publications (1)
- BACKGROUNDCornell RF, Bishop MR, Kumar S, Giralt SA, Nooka AK, Larson SM, Locke FL, Raje NS, Lei L, Dong J, Le Gall JB, Rossi JM, Orlowski RZ. A phase 1, multicenter study evaluating the safety and efficacy of KITE-585, an autologous anti-BCMA CAR T-cell therapy, in patients with relapsed/refractory multiple myeloma. Am J Cancer Res. 2021 Jun 15;11(6):3285-3293. eCollection 2021. PMID 34249462