Can a cancer drug reboot the immune system after a stem cell transplant?

NCT ID NCT05346809

Disease control Sponsor: Divaya Bhutani Source: ClinicalTrials.gov ↗

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding isatuximab to standard stem cell transplant procedures can help the immune system better fight multiple myeloma and certain lymphomas. Participants are randomly assigned to receive either standard transplant care alone or isatuximab plus standard care. The study measures changes in immune cell counts and tracks side effects to see if the drug improves recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: isatuximab (Sarclisa) given intravenously alongside standard transplant procedures
What this could lead to: If it works, this could point toward a way to help the immune system fight blood cancers more effectively after a stem cell transplant.
What could go wrong: This is a small, early-phase trial with only 8 participants, so results may not apply broadly. Isatuximab can cause infusion reactions and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

8 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Following diagnoses are eligible for inclusion in the study: A) Multiple Myeloma with ASCT used as consolidation after first line induction therapy or at first relapse. B) Relapsed/Refractory Hodgkin's disease C) Non-Hodgkin's Lymphomas as follows * Relapsed/Refractory Diffuse large B cell lymphoma * Relapsed/Refractory indolent or relapsed/refractory transformed indolent B cell lymphomas as consolidation after second line therapy * Mantle Cell lymphoma as consolidation after first-line therapy * Peripheral T cell lymphoma as consolidation after first-line therapy or at relapse or primary refractory disease 2. Patients undergoing first ASCT will be eligible for the study. 3. Any prior therapy for the malignancy except CD38 antibody within the last 12 months is allowed. 4. Age ≥18 years 5. Life expectancy of greater than 6 months. Exclusion Criteria: 1. Previously exposure to a CD38 antibody during the last 12 months. 2. Participants who are receiving any other investigational agents concurrently or received any investigational agent within the last 8 weeks. 3. History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab. 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 5. Pregnant and Lactating women 6. HIV-positive status due to increased risk of infection when treated with immunosuppressive therapy

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Conditions

The condition(s) this trial relates to.

Hodgkins lymphoma indolent B-cell non-Hodgkin lymphoma lymphoma mantle cell lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma non-Hodgkin lymphoma plasma cell myeloma relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma Multiple myeloma Non-Hodgkin lymphoma Relapsed Hodgkin's disease, adult

Can a cancer drug reboot the immune system after a stem cell transplant?

What the study statuses mean