40 Participants NeededMy employer runs this trial

B7-H3 CAR T Cells for Small Cell Lung Cancer

DF
AT
NP
Overseen ByNicholas P Tschernia, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for small cell lung cancer (SCLC) and extrapulmonary neuroendocrine cancer (EPNEC), both aggressive and deadly cancer types. Researchers are testing a therapy that modifies a patient's own immune cells to target and kill cancer cells with a specific protein called B7-H3. The trial evaluates the safety and effectiveness of these modified cells, known as Autologous B7-H3 CAR T cells, for treating these cancers. It suits individuals whose SCLC or EPNEC did not respond to or returned after initial treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications?

Yes, you may need to stop taking certain medications before joining the trial. There are specific timeframes for stopping chemotherapy, biologic agents, steroids, and other treatments before starting the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A study found B7-H3 CAR T-cell therapy to be generally safe for patients with recurring tumors. Most patients tolerated the treatment well, experiencing only minor, non-serious side effects.

Another report showed that injecting B7-H3 CAR-T cells directly into tumors helped control tumor growth and caused only minor unwanted effects, indicating the treatment's relative safety.

While the results are promising, it is important to remember that this is a phase 1 trial. Phase 1 trials are the first step in testing a treatment in humans, focusing mainly on safety. They help determine the best dose and check for any serious side effects. So far, the results suggest that B7-H3 CAR T-cell therapy is safe enough for further testing.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for small cell lung cancer, which typically involve chemotherapy and radiation, the B7-H3 CAR T cell therapy offers a novel approach by harnessing the body's own immune system to fight cancer. This treatment uses genetically engineered T cells that specifically target the B7-H3 protein, commonly found on the surface of cancer cells, allowing for a more precise attack on the tumor. Researchers are excited about this therapy because it has the potential to improve the precision and effectiveness of treatment while minimizing damage to healthy cells. This innovative mechanism of action could lead to better outcomes and fewer side effects compared to traditional therapies.

What evidence suggests that B7-H3 CAR T cell therapy might be an effective treatment for small cell lung cancer?

Research has shown that a new treatment, B7-H3 CAR T cell therapy, could help treat small cell lung cancer (SCLC) and similar cancers. Early studies found that these specially modified T cells can locate and destroy cancer cells with the B7-H3 protein. Lab tests demonstrated strong effects against tumors, suggesting this method might work well for solid tumors. In this trial, participants will receive escalating doses of autologous B7-H3 CAR T cells to determine the maximum tolerated dose. Treatments targeting B7-H3, including CAR T cells, have shown promising results in early trials, prompting further investigation. While more information is needed, these findings offer hope for people with SCLC and extrapulmonary neuroendocrine cancer (EPNEC).12467

Who Is on the Research Team?

NP

Nicholas P Tschernia, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for adults (18+) with small cell lung cancer or extrapulmonary neuroendocrine cancers that have come back or didn't respond to previous treatment. Participants need decent organ function, enough blood cells, and must be well enough to handle hospital care.

Inclusion Criteria

* Platelet count \>= 75,000/mcL.
I am 18 years old or older.
* Creatinine \<=1.5 X institutional ULN.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Apheresis

Participants undergo apheresis for T cell selection and modification

1 week
1 visit (in-person)

Chemotherapy

Participants receive chemotherapy drugs to prepare their body for the CAR T cell infusion

1 week
Inpatient stay

CAR T Cell Infusion

Modified T cells are infused through a vein, and participants remain in the hospital for monitoring

15 days
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 years
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous B7-H3 CAR T

Trial Overview

Researchers are testing a new therapy where a person's own immune cells (T cells) are collected, modified in the lab to target cancer (B7-H3 CAR T), and then given back after chemotherapy drugs cyclophosphamide and fludarabine prepare the body. Hospital stay is required.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions
Group II: Dose EscalationExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

NCT07509034 | Autologous B7-H3 Chimeric Antigen ...

When these modified T cells are returned to the body-a treatment called B7-H3 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.

B7-H3 as a Universal Target for Solid Tumor Therapy

In this issue of the Journal of Clinical Oncology, a phase II single-arm trial treated 137 patients with extensive-stage small cell lung cancer ...

B7-H3 in Cancer Immunotherapy—Prospects and Challenges

B7-H3 targeting therapies, such as monoclonal antibodies, antibody–drug conjugates, and CAR T-cells, present promising results in preclinical studies and are ...

B7-H3 CAR T Cells for Small Cell Lung Cancer

... Autologous B7-H3 CAR T will have tolerable side effects & efficacy for patients with Small Cell Lung Cancer, Relapse, Small Cell Lung Cancer ...

Autologous B7-H3 Chimeric Antigen Receptor... | Clinical Trial

A Phase I Study to Assess the Safety and Antitumor Activity of Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated ...

Case report: B7-H3 CAR-T therapy partially controls tumor ...

In this particular case report, intratumoral injection of B7-H3 CAR-T cells partially controls tumor growth in the BCC patient with minor adverse events.

CAR-T for Lung Cancers: Challenges and Innovations

Allogeneic CAR T cells targeting DLL3 are efficacious and safe in preclinical models of small cell lung cancer ... CAR T cells against non-small cell lung cancer.