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NCT04152148
A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients
Phase 1 trial testing 500mg BAT4306F in Non-Hodgkin's Lymphoma in 16 participants. Completed in 13 January 2021.
13 January 2021
Quick facts
| Lead sponsor | Bio-Thera Solutions |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 4 September 2018 |
| Primary completion | 13 January 2021 |
| Estimated completion | 13 January 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- 500mg BAT4306F — full drug profile →
- 750mg BAT4306F — full drug profile →
- 900mg BAT4306F — full drug profile →
- 1000mg BAT4306F — full drug profile →
Conditions studied
- Non-Hodgkin's Lymphoma — all drugs for Non-Hodgkin's Lymphoma →
Sponsor
Bio-Thera Solutions — full company profile →
Who can join
Adults 18 to 75, any sex, with Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04152148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Bio-Thera Solutions trials
Trials by the same sponsor.
- NCT07499700 — A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis · Phase 2, PHASE3 · recruiting
- NCT07180862 — A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants · Phase 1 · recruiting
- NCT06545617 — A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer · Phase 1, PHASE2 · withdrawn
- NCT07515079 — Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema · Phase 3 · recruiting
- NCT06280196 — A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants Wit · Phase 3 · 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 NCT04152148 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bio-Thera Solutions
- Last refreshed: 8 February 2023
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/NCT04152148.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing