Last reviewed · How we verify
NCT03670888
A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients
Phase 1 trial testing JHL1101 in B Cell Lymphoma in 1 participant. Terminated before completion.
19 March 2019
Quick facts
| Lead sponsor | JHL Biotech, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 16 November 2018 |
| Primary completion | 19 March 2019 |
| Estimated completion | 19 March 2019 |
| Sites | 2 locations across China |
Drugs / interventions tested
Conditions studied
- B Cell Lymphoma — all drugs for B Cell Lymphoma →
Sponsor
JHL Biotech, Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with B Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Biosimilar monoclonal antibodies for cancer treatment in adults.
Galvao TF, Livinalli A, Lopes LC, Zimmermann IR, et al · · 2024 · cited 2× · PMID 39607013 · DOI 10.1002/14651858.cd013539.pub2
Verify or expand the search:
- PubMed search for NCT03670888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of JHL1101
Trials testing the same drug.
- NCT03670901 — A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Lar · Phase 3 · terminated
- NCT03161457 — A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis · Phase 1 · terminated
Other recruiting trials for B Cell Lymphoma
Currently open trials in the same condition.
- NCT07009002 — BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma · Phase 1, PHASE2 · recruiting
- NCT06976437 — A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors · EARLY_PHASE1 · recruiting
- NCT06987916 — Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma · Phase 1, PHASE2 · recruiting
- NCT07101913 — Occurrence of Acute Kidney Injury After CAR-T Cells Treatments in B-cell Lymphoma. · active not recruiting
- NCT06742996 — A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib · Phase 3 · recruiting
Other JHL Biotech, Inc. trials
Trials by the same sponsor.
- NCT03670901 — A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Lar · Phase 3 · terminated
- NCT03576651 — A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers · Phase 1 · completed
- NCT03586076 — A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects · Phase 1 · completed
- NCT03161457 — A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis · 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 NCT03670888 (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 JHL Biotech, Inc.
- Last refreshed: 9 January 2020
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/NCT03670888.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing