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A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Primary Purpose

Relapse/Refractory Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DeepTag-GPRC5D Targeted CAR T-cells
Sponsored by
He Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse/Refractory Multiple Myeloma focused on measuring Multiple Myeloma, DeepTag-GPRC5D CAR T-cell

Eligibility Criteria

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

Inclusion Criteria: 1. Those who voluntarily participated in this trial and provided informed consent; 2. Gender unlimited,18<Age≤75; 3. Estimated life expectancy of minimum of 12 weeks; 4. ECOG 0-2; 5. Diagnosed as multiple myeloma according to the IMWG criteria; 6. Subjects failed treatment with at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors (PIs) ,immunomodulatory agents (IMiDs) and CD38 antibody), or recived the above three treatment methods experienced disease progression or recurrence during the most recent treatment process or within 6 months after the end of treatment, Difficulty in treatment includes primary difficulty in treatment ( patient has not achieved minimal remission or disease progression during treatment) or secondary difficulty in treatment (patient develops disease progression within 60 days after completion of treatment); 7. Women have a negative urine pregnancy test before the start of medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up; 8. The blood routine meets the following standards: Lymphocyte count>0.3×10e9/L; Neutrophils ≥0.5×10e9/L; Hemoglobin ≥60g/L; Platelet ≥30×10e9/L Exclusion Criteria: 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with HIV infection; 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study; 10. Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening; 11. Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment; 12. Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period; 13. Patients received allogeneic stem cell therapy; 14. Any unsuitable to participate in this trial judged by the investigator.

Sites / Locations

  • The first affiliated hospital of medical college of zhejiang universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of DeepTag-GPRC5D Targeted CAR T-cells

Arm Description

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome Measures

Multiple Myeloma (MM), Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR)
Progression-free survival (PFS)
The time from randomization or start of study treatment until objective tumor progression or death
Duration of remission,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
He Huang
Collaborators
Yake Biotechnology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06084962
Brief Title
A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Official Title
A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
October 20, 2026 (Anticipated)
Study Completion Date
October 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
He Huang
Collaborators
Yake Biotechnology Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Detailed Description
In this study, 60 patients with relapsed refractory multiple myeloma were proposed to undergo DeepTag-GPRC5D CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of DeepTag-GPRC5D CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on DeepTag-GPRC5D CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse/Refractory Multiple Myeloma
Keywords
Multiple Myeloma, DeepTag-GPRC5D CAR T-cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of DeepTag-GPRC5D Targeted CAR T-cells
Arm Type
Experimental
Arm Description
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Intervention Type
Biological
Intervention Name(s)
DeepTag-GPRC5D Targeted CAR T-cells
Other Intervention Name(s)
DeepTag-GPRC5D Targeted CAR T-cells injection
Intervention Description
Each subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT)
Description
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time Frame
Up to 28 years after Treatment
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time Frame
Up to 2 years after Treatment
Secondary Outcome Measure Information:
Title
Multiple Myeloma (MM), Overall response rate (ORR)
Description
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR)
Time Frame
Up to 2 years after Treatment
Title
Progression-free survival (PFS)
Description
The time from randomization or start of study treatment until objective tumor progression or death
Time Frame
Up to 2 years after Treatment
Title
Duration of remission,DOR
Description
The time from CR/CRi and PR to disease relapsed or death due to disease
Time Frame
Up to 1 years after Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Those who voluntarily participated in this trial and provided informed consent; 2. Gender unlimited,18<Age≤75; 3. Estimated life expectancy of minimum of 12 weeks; 4. ECOG 0-2; 5. Diagnosed as multiple myeloma according to the IMWG criteria; 6. Subjects failed treatment with at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors (PIs) ,immunomodulatory agents (IMiDs) and CD38 antibody), or recived the above three treatment methods experienced disease progression or recurrence during the most recent treatment process or within 6 months after the end of treatment, Difficulty in treatment includes primary difficulty in treatment ( patient has not achieved minimal remission or disease progression during treatment) or secondary difficulty in treatment (patient develops disease progression within 60 days after completion of treatment); 7. Women have a negative urine pregnancy test before the start of medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up; 8. The blood routine meets the following standards: Lymphocyte count>0.3×10e9/L; Neutrophils ≥0.5×10e9/L; Hemoglobin ≥60g/L; Platelet ≥30×10e9/L Exclusion Criteria: 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with HIV infection; 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study; 10. Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening; 11. Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment; 12. Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period; 13. Patients received allogeneic stem cell therapy; 14. Any unsuitable to participate in this trial judged by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, MD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxian Hu, MD
Phone
86-15957162012
Email
huyongxian2000@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of medical college of zhejiang university
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name & Degree
Yongxian Hu, MD
Phone
+8615957162012
Email
huyongxian2000@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

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