NCT03331198

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Official title

An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

Phase

Phase 1/Phase 2

Status

Active not recruiting

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Small Lymphocytic

Interventions

JCAR017 (lisocabtagene maraleucel); JCAR017 (lisocabtagene maraleucel) + ibrutinib; JCAR017 (lisocabtagene maraleucel) + venetoclax

Arms

• Phase 1 JCAR017 monotherapy · Experimental
• Phase 1 JCAR017 + ibrutinib · Experimental
• Phase 2 JCAR017 monotherapy · Experimental
• Phase 1 JCAR017 + venetoclax · Experimental
• Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME) · Experimental

Enrollment

320 (estimated)

Primary outcomes

• Phase 1 JCAR017 monotherapy arm: adverse events
• Phase 1 JCAR017 monotherapy arm: laboratory abnormalities
• Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events
• Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities
• Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm
• Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse events
• Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalities
• Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm
• Phase 2 JCAR017 monotherapy expansion arm
• Phase 2 JCAR017 Double exposed monotherapy expansion arm: overall response rate (ORR)

Sponsor

Juno Therapeutics, a Subsidiary of Celgene

Start

Nov 27, 2017

Primary completion

Nov 26, 2027 (estimated)

Results posted

No

Registry record

NCT03331198 · updated Jul 6, 2026

• Wierda WG, Dorritie KA, Gauthier J, Nath R, Kipps TJ, Riedell PA, Eradat HA, Kenderian SS, Kharfan-Dabaja MA, Shah NN, Solomon SR, Stephens DM, Ermann DA, Arnason JE, Deol A, Feldman TA, Andreadis CB, Ghosh M, Ma S, Schuster SJ, Gergis U, Vose JM, Soumerai JD, van Besien K, Tuazon SA, Perna SK, Ou SS, Ananthakrishnan R, Rane N, Papp E, Ansari S, Thompson EG, Okal A, Peiser L, Chen Y, Sengupta S, Ray PR, Wang J, Siddiqi T. Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004. Blood. 2026 Jul 28:blood.2026033565. doi: 10.1182/blood.2026033565. Online ahead of print. PubMed 42520199
• Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, Riedell PA, Shah NN, Nath R, Fakhri B, Stephens DM, Ma S, Feldman T, Solomon SR, Schuster SJ, Perna SK, Tuazon SA, Ou SS, Papp E, Peiser L, Chen Y, Wierda WG. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. Lancet. 2023 Aug 19;402(10402):641-654. doi: 10.1016/S0140-6736(23)01052-8. Epub 2023 Jun 6. PubMed 37295445
• Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21. PubMed 35610089
• Siddiqi T, Soumerai JD, Dorritie KA, Stephens DM, Riedell PA, Arnason J, Kipps TJ, Gillenwater HH, Gong L, Yang L, Ogasawara K, Thorpe J, Wierda WG. Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL. Blood. 2022 Mar 24;139(12):1794-1806. doi: 10.1182/blood.2021011895. PubMed 34699592