NCT05346809 is a Phase 2 clinical trial of Isatuximab in Lymphoma, sponsored by Divaya Bhutani.

Who is sponsoring NCT05346809?

NCT05346809 is sponsored by Divaya Bhutani.

What drugs are being tested in NCT05346809?

Interventions in NCT05346809: Isatuximab, Standard Procedures.

What condition does NCT05346809 study?

NCT05346809 studies Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult.

Is NCT05346809 still recruiting?

NCT05346809 is currently recruiting now. Last updated 4 June 2025.

Last reviewed 2025-06-04 · How we verify

NCT05346809

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

Randomized Phase 2 Trial of Isatuximab During Autologous Stem Cell Collection and Transplantation Period in Patients With Multiple Myeloma, Relapsed Hodgkin's and Non-Hodgkin's Lymphoma

Recruiting now Phase 2 Last updated 4 June 2025

What this trial tests

Phase 2 trial testing Isatuximab in Lymphoma in 39 participants. Currently enrolling.

Timeline

31 March 2023

Primary endpoint
1 September 2026

1 September 2026

Quick facts

Lead sponsor	Divaya Bhutani
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	31 March 2023
Primary completion	1 September 2026
Estimated completion	1 September 2026
Sites	2 locations across United States

Drugs / interventions tested

Isatuximab (isatuximab) — full drug profile →
Standard Procedures

Conditions studied

Lymphoma — all drugs for Lymphoma →
Multiple Myeloma — all drugs for Multiple Myeloma →
Non-Hodgkin Lymphoma — all drugs for Non-Hodgkin Lymphoma →
Relapsed Hodgkin's Disease, Adult — all drugs for Relapsed Hodgkin's Disease, Adult →

Sponsor

Divaya Bhutani

Who can join

18 and older, any sex, with Lymphoma or Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in the total lymphocyte count
Time frame: Day 30
Change in total lymphocyte count measured from blood sample

Sponsor's own description

The purpose of this study is to see if Isatuximab can alter the immune system in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. The investigators will see if Isatuximab makes changes to the immune system so that upon recovery from the transplant, the immune system can fight the cancer. This study will have two arms. On one arm (control arm), participants will receive standard transplant procedures and on the other arm (experimental arm), participants will receive Isatuximab in addition to the standard transplant procedures. The assignment to these arms is done randomly (determined by chance, like flipping a coin) by a computer. Each participant will have about 66% chance of getting on the experimental arm and about 33% chance of getting on the control arm.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The role of transplantation in Hodgkin lymphoma.
Maranzano M, Mead M. · · 2022 · cited 9× · PMID 36776370 · DOI 10.3389/fonc.2022.1054314

Verify or expand the search:

Other trials of Isatuximab

Trials testing the same drug.

NCT07045909 — Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST) · Phase 2 · recruiting
NCT05862766 — Isatuximab in Lung Transplant Recipients · EARLY_PHASE1 · withdrawn
NCT05922501 — Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma · Phase 2 · recruiting
NCT06182774 — Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Mu · Phase 3 · recruiting
NCT06203912 — Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma · Phase 1 · active not recruiting

Other recruiting trials for Lymphoma

Currently open trials in the same condition.

NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06856226 — Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing · recruiting
NCT07226934 — An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers · NA · recruiting
NCT07138547 — GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma · Phase 1, PHASE2 · recruiting

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 NCT05346809 (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 Divaya Bhutani
Last refreshed: 4 June 2025

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/NCT05346809.

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