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

• Sponsor: He Huang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06084962
• Collaborator: Yake Biotechnology Ltd. (Industry)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapse/Refractory Multiple Myeloma	Biological: DeepTag-GPRC5D Targeted CAR T-cells	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
• Anticipated Study Start Date: Oct 20, 2023
• Anticipated Primary Completion Date: Oct 20, 2026
• Anticipated Study Completion Date: Oct 20, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: DeepTag-GPRC5D Targeted CAR T-cells; Each subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion; Other Names: DeepTag-GPRC5D Targeted CAR T-cells injection

Outcome Measures

Primary Outcome Measures

1. Dose-limiting toxicity (DLT) [Up to 28 years after Treatment]

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

2. Incidence of treatment-emergent adverse events (TEAEs) [Up to 2 years after Treatment]

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

Secondary Outcome Measures

1. Multiple Myeloma (MM), Overall response rate (ORR) [Up to 2 years after Treatment]

   Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR)

2. Progression-free survival (PFS) [Up to 2 years after Treatment]

   The time from randomization or start of study treatment until objective tumor progression or death

3. Duration of remission,DOR [Up to 1 years after Treatment]

   The time from CR/CRi and PR to disease relapsed or death due to disease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Those who voluntarily participated in this trial and provided informed consent;
• 1. Gender unlimited，18<Age≤75;
• 1. Estimated life expectancy of minimum of 12 weeks;
• 1. ECOG 0-2;
• 1. Diagnosed as multiple myeloma according to the IMWG criteria;
• 1. 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);
• 1. 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;
• 1. 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;
• 1. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• 1. Pregnant (or lactating) women;
• 1. Patients with HIV infection;
• 1. Active infection of hepatitis B virus or hepatitis C virus;
• 1. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
• 1. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 1. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
• 1. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study;
• 1. Patients who received anti-cancer chemotherapy or other medications within 2 weeks before screening;
• 1. Uncontrolled malignant tumors except MM, excluding malignant tumors that received radical treatment and no active disease was found within 3 years before enrollment;
• 1. Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during the study period;
• 1. Patients received allogeneic stem cell therapy;
• 1. Any unsuitable to participate in this trial judged by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• He Huang
• Yake Biotechnology Ltd.

Investigators

• Principal Investigator: He Huang, MD, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: He Huang, Clinical Professor, Zhejiang University
• ClinicalTrials.gov Identifier: NCT06084962
• Other Study ID Numbers: TXB2023018
• First Posted: Oct 16, 2023
• Last Update Posted: Oct 16, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by He Huang, Clinical Professor, Zhejiang University: Multiple Myeloma; DeepTag-GPRC5D CAR T-cell
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Oct 16, 2023