Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID06791681

Clinical Study for Evaluating ESO-T01 Injection's Safety and Efficacy in Treating Relapsed/Refractory Multiple Myeloma

Led by Chunrui Li · Updated on 2025-02-11

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Chunrui Li

Lead Sponsor

S

Shenzhen Pregene Biopharma Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate ESO-T01 injection for patients with relapsed or refractory multiple myeloma. This early-phase clinical study focuses on observing the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of ESO-T01, a third-generation lentiviral vector that targets T cells in vivo with a BCMA-directed CAR. The study is designed for patients who have had prior treatments but continue to experience disease progression. ESO-T01 is given through infusion after patients receive preventive medications acetaminophen and diphenhydramine. The study uses a dose-escalation design with four different dose levels labeled A, B, C, and D. Following infusion, participants will be monitored closely for two years to assess various outcomes. Participants will have multiple assessments including evaluation of dose-limiting toxicities, immune-related side effects like cytokine release syndrome and neurotoxicity up to 28 days post-infusion, and treatment-related adverse effects for two years. Researchers will also measure response rates, survival outcomes, and detailed pharmacokinetic parameters at scheduled intervals up to two years. Continuous monitoring will help understand the treatment's effects and safety profile over time.

CONDITIONS

Brief Title

A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed diagnosis of multiple myeloma with BCMA expression on myeloma cells
  • Previously treated with at least two anti-myeloma therapies with documented disease progression
  • Measurable disease at screening based on serum or urine M-protein or free light chain levels
  • ECOG performance status of 0 to 2 with expected survival of at least 3 months
  • Adequate bone marrow function including minimum levels for hemoglobin, neutrophils, platelets, lymphocytes, and CD3-positive T cells
  • Normal renal function with creatinine clearance of 45 mL/min or higher
  • Liver function tests within defined limits including ALT, AST, bilirubin, and albumin
  • Adequate cardiac function including left ventricular ejection fraction of 40% or higher and no significant ECG or pericardial abnormalities
  • Pulmonary function with oxygen saturation of at least 90% and no significant pleural effusion
  • Negative pregnancy test for women of childbearing potential who are not breastfeeding
  • Use of effective contraception and agreement not to donate reproductive cells from consent until 1 year after treatment
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Recent anticancer treatments including targeted, epigenetic, immune, cytotoxic therapies, or radiotherapy within specified timeframes
  • Allogeneic stem cell transplant within 6 months or autologous transplant within 3 months prior to infusion
  • Other malignancies except certain treated cancers without active disease for at least 2 years
  • Previous treatment with viral therapy using VSVG pseudotype virus
  • Serious uncontrolled infections at screening
  • Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with active infection
  • Significant heart conditions including advanced heart failure, recent heart attack or surgery, serious arrhythmias, or cardiomyopathy
  • Other serious diseases such as primary immunodeficiency, recent stroke or seizure, dementia, or Parkinson’s disease
  • Recent surgery within 2 weeks before or planned within 2 weeks after treatment
  • Use of live vaccines within 1 month before treatment
  • Known severe allergic reactions to ESO-T01, its components, or tocilizumab
  • Inability to establish venous access
  • Any other condition the investigator considers unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 28 days

Participants receive a single infusion of ESO-T01 drug with prior prophylaxis medication and dose escalation through four dose groups.

1 infusion visit and multiple monitoring visits up to Day 28

Follow-up

Duration - Up to 2 years

Participants are followed for safety and efficacy assessments for up to 2 years after treatment.

Regular visits for assessments at Day 14, Day 28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24

Trial Site Locations

Total: 1 location

1

Tongji Hospital, Tongji Medical College

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

C

Chunrui Li

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial