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CAR T-cell Therapy

CAR T Therapy for Multiple Myeloma

Phase 1 & 2

Recruiting

Research Sponsored by Gracell Biopharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an ECOG performance status of 0 or 1

Received at least three prior MM treatment lines of therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial tests a new cancer treatment for people with advanced multiple myeloma.

Who is the study for?

Adults with relapsed/refractory Multiple Myeloma who have tried at least three treatment lines including a PI, IMiD, and an antiCD38 antibody. They must have measurable disease, good bone marrow and organ function, be over 18 years old with an ECOG status of 0 or 1. Exclusions include other cancers within the last two years (except certain skin cancers), severe heart issues, CNS involvement by myeloma, specific related diseases like POEMS syndrome or AL amyloidosis.Check my eligibility

What is being tested?

The trial is testing GC012F, a dual-targeting CAR T therapy aimed at CD19 and BCMA in patients with multiple myeloma that has come back or hasn't responded to treatment. It's an early-phase study where all participants receive the experimental therapy to evaluate its safety and effectiveness.See study design

What are the potential side effects?

Potential side effects may include immune system reactions due to cell targeting which can affect normal cells as well as cancerous ones; symptoms could range from mild allergic responses to more serious conditions affecting blood counts or organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have undergone at least three different treatments for multiple myeloma.

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I've been treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

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My condition is officially diagnosed as multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b Adverse Events (AEs)

Phase 1b Dose-limiting toxicities

Phase 2 Overall response rate (ORR)

Secondary outcome measures

Phase 1b Pharmacokinetic - AUC

Phase 1b Pharmacokinetic - Cmax

Phase 1b Pharmacokinetic - Tmax

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: GC012FExperimental Treatment1 Intervention

GC012F will be administrated in one infusion

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gracell Biopharmaceuticals, Inc.Lead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

Yingda WenStudy DirectorGracell Biopharmaceuticals, Inc.

Media Library

GC012F (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05850234 — Phase 1 & 2

Multiple Myeloma Research Study Groups: GC012F

Multiple Myeloma Clinical Trial 2023: GC012F Highlights & Side Effects. Trial Name: NCT05850234 — Phase 1 & 2

GC012F (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05850234 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals is this trial recruiting?

"This clinical trial requires 68 volunteers that meet the eligibility criteria. Participants will have the option to register at one of two locations: Icahn School of Medicine at Mount Sinai in New york, NY or SCRI Tennessee Oncology in Nashville, TN."

Answered by AI

What objective is this trial intended to achieve?

"This clinical trial will assess the Phase 1b Adverse Events (AEs) over a 4-week period, with secondary objectives being to quantify Time to Maximum GC012F level and record further safety data through incidence of AEs. Additionally, scientists hope to ascertain the maximum GC012F concentration in patients."

Answered by AI

Are there any opportunities for enrollment in this clinical trial presently?

"Indeed, the information posted on clinicaltrials.gov affirms that this trial is in progress and looking for participants. Initially advertised on July 20th 2023, it has since been updated twice; most recently on August 7th 2023. Aspiring patients must be admitted to one of four different medical centres with a total number of spots available equalling 68."

Answered by AI

What is the geographic spread of this research endeavor?

"The research team is enlisting patients from 4 definitive locations, including Icahn School of Medicine at Mount Sinai in New york, SCRI Tennessee Oncology in Nashville and SAMC South Austin Medical Center. There are also additional sites available for enrolment purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma

2023. "A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05850234.