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CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Not yet recruiting

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

CXCR4 modified anti-BCMA CAR T cells

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients with other uncontrollable cancer
Active hepatitis B, hepatitis C, or HIV infection
Other uncontrolled active disease
Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
Patients with uncontrollable hypertension(≥ grade II)
Patients with history of uncontrollable mental illness
Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
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;
Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
Patients had other conditions that were not appropriate for the study determined by the researchers.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CXCR4 modified anti-BCMA CAR T cell therapy

Arm Description

CAR T cell therapy

Outcomes

Primary Outcome Measures

Dose limiting toxicities (DLT)

Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

ORR (overall response rate)

Proportion of subjects with the best overall response (BOR)

CRR (complete response rate)

Proportion of subjects with the BOR of sCR+CR at Month 3

Full Information

NCT ID

NCT04727008

First Posted

November 30, 2020

Last Updated

April 7, 2021

Sponsor

Sichuan University

1. Study Identification

Unique Protocol Identification Number

NCT04727008

Brief Title

CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 3, 2021 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CXCR4 modified anti-BCMA CAR T cell therapy

Arm Type

Experimental

Arm Description

CAR T cell therapy

Intervention Type

Biological

Intervention Name(s)

CXCR4 modified anti-BCMA CAR T cells

Intervention Description

intravenous infusion

Primary Outcome Measure Information:

Title

Dose limiting toxicities (DLT)

Description

Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

Time Frame

2 years

Title

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Time Frame

24 months

Secondary Outcome Measure Information:

Title

ORR (overall response rate)

Description

Proportion of subjects with the best overall response (BOR)

Time Frame

3 months，6 months

Title

CRR (complete response rate)

Description

Proportion of subjects with the BOR of sCR+CR at Month 3

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, 18 to 75 years old. The expected survival ≥ 12 week ECOG ≤ 2 Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection Patients can take effective contraceptive measures during the trial period and 1 year after the infusion Voluntary informed consent is given, agree to follow the trial treatment and visit plan Exclusion Criteria: Patients with other uncontrollable cancer Active hepatitis B, hepatitis C, or HIV infection Other uncontrolled active disease Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases Patients with uncontrollable hypertension(≥ grade II) Patients with history of uncontrollable mental illness Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded) Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment; 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; Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment; Patients had other conditions that were not appropriate for the study determined by the researchers.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

DAN LI, Ph.D

Phone

+86(028)85423525

lidan@wchscu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

FUCHUN GUO, MD

Phone

+86(028)85423525

FCguo0797@wchscu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

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