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

NCT06084962 | Recruiting Phase 1

• 1 other identifier: TXB2023018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

Conditions

Relapse/Refractory Multiple Myeloma

Keywords

Multiple Myeloma; DeepTag-GPRC5D CAR T-cell

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Up to 28 years after Treatment

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  Up to 2 years after Treatment

Secondary Outcomes (3)

• Multiple Myeloma (MM), Overall response rate (ORR)

  Up to 2 years after Treatment

• Progression-free survival (PFS)

  Up to 2 years after Treatment

• Duration of remission,DOR

  Up to 1 years after Treatment

Study Arms (1)

Administration of DeepTag-GPRC5D Targeted CAR T-cells

EXPERIMENTAL

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

Biological: DeepTag-GPRC5D Targeted CAR T-cells

Interventions

DeepTag-GPRC5D Targeted CAR T-cells BIOLOGICAL

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

Also known as: DeepTag-GPRC5D Targeted CAR T-cells injection

Administration of DeepTag-GPRC5D Targeted CAR T-cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Those who voluntarily participated in this trial and provided informed consent;
• \. Gender unlimited，18\<Age≤75;
• \. Estimated life expectancy of minimum of 12 weeks;
• \. ECOG 0-2;
• \. Diagnosed as multiple myeloma according to the IMWG criteria;
• \. 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);
• \. 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;
• \. 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

You may not qualify if:

• \. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• \. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• \. Pregnant (or lactating) women;
• \. Patients with HIV infection;
• \. Active infection of hepatitis B virus or hepatitis C virus;
• \. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
• \. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• \. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
• \. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study;
• \. Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening;
• \. Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment;
• \. Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period;
• \. Patients received allogeneic stem cell therapy;
• \. Any unsuitable to participate in this trial judged by the investigator.

Sponsors & Collaborators

• He Huang: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• He Huang, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, MD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: October 16, 2023

Record last verified: 2023-09

Locations

CN (1)