NCT03836768 is a Phase 1 clinical trial of DTRMWXHS-12 in Mantle Cell Lymphoma, sponsored by Zhejiang DTRM Biopharma.

Who is sponsoring NCT03836768?

NCT03836768 is sponsored by Zhejiang DTRM Biopharma.

What drugs are being tested in NCT03836768?

Interventions in NCT03836768: DTRMWXHS-12.

What condition does NCT03836768 study?

NCT03836768 studies Mantle Cell Lymphoma.

Is NCT03836768 still recruiting?

NCT03836768 is currently completed. Last updated 15 February 2023.

Last reviewed 2023-02-15 · How we verify

NCT03836768

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma

Completed Phase 1 Last updated 15 February 2023

What this trial tests

Phase 1 trial testing DTRMWXHS-12 in Mantle Cell Lymphoma in 20 participants. Completed in 17 November 2021.

Timeline

11 January 2019

Primary endpoint
17 November 2021

17 November 2021

Quick facts

Lead sponsor	Zhejiang DTRM Biopharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	11 January 2019
Primary completion	17 November 2021
Estimated completion	17 November 2021
Sites	1 location across China

Drugs / interventions tested

DTRMWXHS-12 — full drug profile →

Conditions studied

Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →

Sponsor

Zhejiang DTRM Biopharma — full company profile →

Who can join

Adults 18 to 75, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Primary Objective is to evaluate the safety and tolerability of the DTRMWXHS-12 capsule in patients with relapsed/refractory MCL and recommend the dose and dosing method (RP2D) used in phase II study. The Secondary Objective is to evaluate the pharmacokinetics (PK) of multiple dose oral administration of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL. The Exploratory Objective is to preliminarily evaluate the efficacy of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Small Molecule NF-κB Pathway Inhibitors in Clinic.
Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
BTK inhibitors in the treatment of hematological malignancies and inflammatory diseases: mechanisms and clinical studies.
Alu A, Lei H, Han X, Wei Y, et al · · 2022 · cited 88× · PMID 36183125 · DOI 10.1186/s13045-022-01353-w

Verify or expand the search:

Other recruiting trials for Mantle Cell Lymphoma

Currently open trials in the same condition.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L · Phase 2 · recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting
NCT06854003 — BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Fo · Phase 2 · recruiting

Other Zhejiang DTRM Biopharma trials

Trials by the same sponsor.

NCT04305444 — Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin's Lymphomas · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03836768 (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 Zhejiang DTRM Biopharma
Last refreshed: 15 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/NCT03836768.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing