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

NCT ID: NCT06084962

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2026-10-20

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.

Conditions

Relapse/Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of DeepTag-GPRC5D Targeted CAR T-cells

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

Group Type: EXPERIMENTAL

DeepTag-GPRC5D Targeted CAR T-cells

Intervention Type: BIOLOGICAL

Each subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion

Interventions

DeepTag-GPRC5D Targeted CAR T-cells

Each subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

DeepTag-GPRC5D Targeted CAR T-cells injection

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:

1. Lymphocyte count>0.3×10e9/L;

2. Neutrophils ≥0.5×10e9/L;

3. Hemoglobin ≥60g/L;

4. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

He Huang

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, MD

Role: CONTACT

hehuangyu@126.com

86-13605714822

Yongxian Hu, MD

Role: CONTACT

huyongxian2000@aliyun.com

86-15957162012

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

86-13605714822

Yongxian Hu, MD

Role: backup

huyongxian2000@aliyun.com

+8615957162012

Other Identifiers

TXB2023018

Identifier Type: -

Identifier Source: org_study_id