Only 44 spots left

~44 spots leftby Apr 2027

CAR T Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AstraZeneca

Must be taking: PI, IMiD, antiCD38

Disqualifiers: Invasive malignancy, Cardiac conditions, CNS involvement, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new therapy using modified immune cells to treat adults with a type of blood cancer that has returned or not responded to treatment. The therapy aims to target and kill cancer cells by recognizing specific proteins on them. This new approach enhances the patient's own immune cells to detect and eliminate cancer cells.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment GC012F, AZD0120 for multiple myeloma?

Research shows that CAR T-cell therapy, which is part of the treatment, has been effective in treating multiple myeloma, especially in patients who have tried many other treatments. Studies have shown high response rates, with some patients experiencing long-term remissions.¹ ² ³ ⁴ ⁵

What is the safety profile of CAR T-cell therapy for multiple myeloma?

CAR T-cell therapy for multiple myeloma has shown manageable safety concerns, including cytokine release syndrome (a condition where the immune system releases too many proteins into the blood too quickly) and neurotoxicity (nerve damage). These side effects can be severe but are generally reversible.¹ ² ³ ⁶ ⁷

What makes the CAR T therapy GC012F unique for treating multiple myeloma?

GC012F, a CAR T-cell therapy, is unique because it targets specific antigens on cancer cells, such as B-cell maturation antigen (BCMA), which are not targeted by traditional treatments like proteasome inhibitors or monoclonal antibodies. This therapy uses modified T-cells to directly attack cancer cells, offering a novel approach for patients who have not responded to other treatments.¹ ³ ⁸ ⁹ ¹⁰

Research Team

Yingda Wen

Principal Investigator

Gracell Biopharmaceuticals, Inc.

Eligibility Criteria

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.

Inclusion Criteria

My bone marrow and organs are functioning well.

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

Your medical records show that your disease has been getting worse according to specific criteria.

See 6 more

Exclusion Criteria

I have a history of severe heart muscle disease not caused by poor blood flow.

I had a stem cell transplant less than 6 months ago and have no GVHD.

My multiple myeloma has affected or is affecting my brain or spinal cord.

See 5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Evaluation of safety, tolerability, pharmacokinetics, and pharmacodynamics of GC012F (AZD0120) in subjects with relapsed/refractory Multiple Myeloma

4 weeks

1 infusion, multiple follow-up visits

Phase 2 Treatment

Evaluation of efficacy and further characterization of safety, pharmacodynamics, and immunogenicity of GC012F (AZD0120)

2 years

1 infusion, regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

GC012F (CAR T-cell Therapy)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: GC012F (AZD0120)Experimental Treatment1 Intervention

GC012F (AZD0120) will be administrated in one infusion

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Gracell Biopharmaceuticals, Inc.

Lead Sponsor

Trials

Recruited

90+

Findings from Research

Chimeric antigen receptor (CAR)-T cell therapy shows promising efficacy and manageable toxicity in heavily pretreated multiple myeloma patients, with over 50 ongoing clinical trials exploring various CAR-T designs and targets.

The most effective CAR-T therapy so far targets B cell maturation antigen, but challenges remain, including the duration of response and the risk of prolonged cytopenia, necessitating further research to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of CAR-T cell therapies for multiple myeloma.Gagelmann, N., Riecken, K., Wolschke, C., et al.[2021]

BCMA CAR T-cell therapy has shown impressive response rates of 60% to 100% in patients with relapsed/refractory myeloma, indicating its potential as a highly effective treatment option.

While the therapy can lead to severe but reversible toxicities like cytokine release syndrome and neurotoxicity, ongoing studies aim to enhance its safety and efficacy through combinations with other treatments and gene editing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAR T Cells and Other Cellular Therapies for Multiple Myeloma: 2018 Update.Cohen, AD.[2019]

CAR T-cell therapy targeting B-cell maturation antigen (BCMA) has shown promising results in treating multiple myeloma, with high-quality responses observed in heavily pretreated patients, and ongoing Phase 3 trials are comparing its efficacy against standard treatments.

While CAR T-cell therapy can lead to sustained responses in some patients, most eventually relapse due to factors like loss of CAR T cells or antigen expression, prompting research into improving CAR design and safety measures, such as suicide gene systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAR T-cell therapy for multiple myeloma: state of the art and prospects.van de Donk, NWCJ., Usmani, SZ., Yong, K.[2021]