NCT04088903 is a Phase 1 clinical trial of Daratumumab in Allosensitization, sponsored by Ronald Witteles.

Who is sponsoring NCT04088903?

NCT04088903 is sponsored by Ronald Witteles.

What drugs are being tested in NCT04088903?

Interventions in NCT04088903: Daratumumab.

What condition does NCT04088903 study?

NCT04088903 studies Allosensitization, Heart Transplant Failure and Rejection.

Is NCT04088903 still recruiting?

NCT04088903 is currently withdrawn. Last updated 28 October 2020.

Last reviewed 2020-10-28 · How we verify

NCT04088903

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

Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart Transplantation

Withdrawn Phase 1 Last updated 28 October 2020

What this trial tests

Phase 1 trial testing Daratumumab in Allosensitization. Withdrawn.

Timeline

1 April 2021

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	Ronald Witteles
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 April 2021
Primary completion	1 April 2023
Estimated completion	1 April 2023

Drugs / interventions tested

Daratumumab (daratumumab) — full drug profile →

Conditions studied

Allosensitization — all drugs for Allosensitization →
Heart Transplant Failure and Rejection — all drugs for Heart Transplant Failure and Rejection →

Sponsor

Ronald Witteles

Who can join

Adults 18 to 75, any sex, with Allosensitization or Heart Transplant Failure and Rejection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to test whether daratumumab, a drug that eliminates antibody-producing plasma cells, can effectively lower the level of preformed antibodies in patients awaiting heart transplantation. These preformed antibodies limit the number of donor hearts that are compatible for the patients. If daratumumab can effectively remove preformed, donor-specific antibodies, then highly allosensitized patients will have more compatible hearts available to them, potentially decreasing transplant waitlist time and reducing mortality.

Publications & conference data

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

Therapeutic Opportunities with Pharmacological Inhibition of CD38 with Isatuximab.
Martin TG, Corzo K, Chiron M, Velde HV, et al · · 2019 · cited 103× · PMID 31779273 · DOI 10.3390/cells8121522
Evaluating Daratumumab in the Treatment of Multiple Myeloma: Safety, Efficacy and Place in Therapy.
Dima D, Dower J, Comenzo RL, Varga C. · · 2020 · cited 36× · PMID 32904669 · DOI 10.2147/cmar.s212526
HLA Desensitization in Solid Organ Transplantation: Anti-CD38 to Across the Immunological Barriers.
Joher N, Matignon M, Grimbert P. · · 2021 · cited 31× · PMID 34093594 · DOI 10.3389/fimmu.2021.688301
Emerging New Approaches in Desensitization: Targeted Therapies for HLA Sensitization.
Choi AY, Manook M, Olaso D, Ezekian B, et al · · 2021 · cited 25× · PMID 34177960 · DOI 10.3389/fimmu.2021.694763
Current Desensitization Strategies in Heart Transplantation.
Habal MV. · · 2021 · cited 19× · PMID 34504489 · DOI 10.3389/fimmu.2021.702186

Verify or expand the search:

Other trials of Daratumumab

Trials testing the same drug.

NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
NCT07393282 — A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) · Phase 3 · not yet recruiting
NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi · Phase 3 · recruiting

Other Ronald Witteles trials

Trials by the same sponsor.

NCT04610320 — Daratumumab-SC for Highly Sensitized Patients Awaiting Heart Transplantation · Phase 1 · completed

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 NCT04088903 (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 Ronald Witteles
Last refreshed: 28 October 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/NCT04088903.

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