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NCT02223598: CLC-102
A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies
Phase 1 trial testing CB-5083 in Lymphoid Hematological Malignancies in 120 participants. Terminated before completion.
26 July 2017
Quick facts
| Lead sponsor | Cleave Biosciences, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 25 August 2014 |
| Primary completion | 26 July 2017 |
| Estimated completion | 26 July 2017 |
| Sites | 8 locations across Canada, United States |
Drugs / interventions tested
- CB-5083 — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Lymphoid Hematological Malignancies — all drugs for Lymphoid Hematological Malignancies →
- Relapsed and Refractory Multiple Myeloma — all drugs for Relapsed and Refractory Multiple Myeloma →
Sponsor
Cleave Biosciences, Inc.
Who can join
18 and older, any sex, with Lymphoid Hematological Malignancies or Relapsed and Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the safety, tolerability, dose limiting toxicities, and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
VCP inhibitors induce endoplasmic reticulum stress, cause cell cycle arrest, trigger caspase-mediated cell death and synergistically kill ovarian cancer cells in combination with Salubrinal.
Bastola P, Neums L, Schoenen FJ, Chien J. · · 2016 · cited 71× · PMID 27729194 · DOI 10.1016/j.molonc.2016.09.005 -
Valosin-Containing Protein (VCP)/p97: A Prognostic Biomarker and Therapeutic Target in Cancer.
Costantini S, Capone F, Polo A, Bagnara P, et al · · 2021 · cited 62× · PMID 34576340 · DOI 10.3390/ijms221810177 -
Crosstalk between endoplasmic reticulum stress and oxidative stress: a dynamic duo in multiple myeloma.
Xiong S, Chng WJ, Zhou J. · · 2021 · cited 61× · PMID 33599798 · DOI 10.1007/s00018-021-03756-3 -
Targeting p97 to Disrupt Protein Homeostasis in Cancer.
Vekaria PH, Home T, Weir S, Schoenen FJ, et al · · 2016 · cited 50× · PMID 27536557 · DOI 10.3389/fonc.2016.00181 -
A p97/Valosin-Containing Protein Inhibitor Drug CB-5083 Has a Potent but Reversible Off-Target Effect on Phosphodiesterase-6.
Leinonen H, Cheng C, Pitkänen M, Sander CL, et al · · 2021 · cited 43× · PMID 33931547 · DOI 10.1124/jpet.120.000486 -
The coordinated action of VCP/p97 and GCN2 regulates cancer cell metabolism and proteostasis during nutrient limitation.
Parzych K, Saavedra-García P, Valbuena GN, Al-Sadah HA, et al · · 2019 · cited 38× · PMID 30626938 · DOI 10.1038/s41388-018-0651-z -
Inadequate fine-tuning of protein synthesis and failure of amino acid homeostasis following inhibition of the ATPase VCP/p97.
Parzych K, Chinn TM, Chen Z, Loaiza S, et al · · 2015 · cited 30× · PMID 26720340 · DOI 10.1038/cddis.2015.373 -
Novel Agents in Multiple Myeloma.
Szalat R, Munshi NC. · · 2019 · cited 21× · PMID 30694859 · DOI 10.1097/ppo.0000000000000355
Verify or expand the search:
- PubMed search for NCT02223598
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CB-5083
Trials testing the same drug.
- NCT02243917 — A Phase 1 Study Evaluating CB-5083 in Subjects With Advanced Solid Tumors · Phase 1 · terminated
Other recruiting trials for Lymphoid Hematological Malignancies
Currently open trials in the same condition.
- NCT07472972 — Dynamic Individualized Risk Profiling of Patients With Relapsed/Refractory Lymphoid Malignancies and CD19-CAR T Cell The · recruiting
- NCT04283006 — A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies · EARLY_PHASE1 · recruiting
Other Cleave Biosciences, Inc. trials
Trials by the same sponsor.
- NCT02243917 — A Phase 1 Study Evaluating CB-5083 in Subjects With Advanced Solid Tumors · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02223598 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cleave Biosciences, Inc.
- Last refreshed: 27 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02223598.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing