CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

December 5, 2023 updated by: Ting Niu, Sichuan University

Phase I Study of A CXCR4 Modified BCMA CAR-T in Patients With Refractory and/or Relapsed Multiple Myeloma

Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, 18 to 75 years old.
  2. The expected survival ≥ 12 week
  3. ECOG ≤ 2
  4. Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
  5. The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
  6. Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
  7. Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
  8. Voluntary informed consent is given, agree to follow the trial treatment and visit plan

Exclusion Criteria:

  1. Patients with other uncontrollable cancer
  2. Active hepatitis B, hepatitis C, or HIV infection
  3. Other uncontrolled active disease
  4. Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
  5. Patients with uncontrollable hypertension(≥ grade II)
  6. Patients with history of uncontrollable mental illness
  7. Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
  8. Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
  9. Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
  10. Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
  11. Patients had other conditions that were not appropriate for the study determined by the researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CXCR4 modified anti-BCMA CAR T cell therapy
CAR T cell therapy
intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicities (DLT)
Time Frame: 2 years
Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
2 years
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (overall response rate)
Time Frame: 3 months,6 months
Proportion of subjects with the best overall response (BOR)
3 months,6 months
CRR (complete response rate)
Time Frame: 3 months
Proportion of subjects with the BOR of sCR+CR at Month 3
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on CXCR4 modified anti-BCMA CAR T cells

3
Subscribe