IMPT-314 for Non-Hodgkin's Lymphoma

Recruiting at 20 trial locations

Overseen By Lyell Immunopharma Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Lyell Immunopharma, Inc.

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Active CNS involvement, Cardiac lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

270 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.

Will I have to stop taking my current medications?

The trial requires that you stop certain medications before enrolling. You must not have received any systemic therapy within 2 weeks, specific immune therapies within 3 half-lives, fludarabine within 12 weeks, and other specified treatments within certain time frames before joining the trial.

Eligibility Criteria

Adults with aggressive B-cell Non-Hodgkin's Lymphoma who've had at least two prior treatments, including an anti-CD20 monoclonal antibody and chemotherapy. They must have a certain level of white blood cells, be in good physical condition (ECOG 0 or 1), and have relapsed or refractory disease after their last treatment. Not eligible if they've recently received other therapies, have ongoing major health issues like heart involvement by lymphoma, autoimmune diseases requiring strong medication within the past two years, or active cancer elsewhere.

Inclusion Criteria

Absolute neutrophil count (ANC) ≥ 1000/uL

At least 1 measurable lesion (the Lugano classification)

My lymphoma is aggressive and confirmed by a biopsy.

Exclusion Criteria

I have received certain treatments within specific time frames before joining.

I am facing an urgent cancer-related health issue.

My heart has been affected by lymphoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Chemotherapy

Participants receive a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide over 3 days

1 week

Treatment

Participants receive a single infusion of CAR-transduced autologous T cells

1 day

Active Post-Treatment

Participants remain in the active post-treatment period for monitoring

2 years

Long-term Follow-up

Participants continue in long-term follow-up for safety and efficacy monitoring

15 years

Treatment Details

Interventions

• IMPT-314

Trial Overview The trial is testing IMPT-314, a new CAR T-cell therapy targeting CD19 and CD20 on cancer cells. It involves modifying a patient's own T-cells to fight cancer and giving them back via infusion after chemotherapy with fludarabine and cyclophosphamide. The study has two phases: Phase 1 for dose finding (60 patients) and Phase 2 for further safety/efficacy evaluation (40 additional participants).

Participant Groups

Group I: Phase 2 CAR T naïve (Cohort 1) Experimental Treatment 3 Interventions

Single dose determined during Phase 1.

Group II: Phase 1 Refractory disease or relapse within one year of first-line therapy (Cohort 3) Experimental Treatment 3 Interventions

Group III: Phase 1 Receiving first-line treatment for high-risk large B-cell lymphoma (Cohort 5) Experimental Treatment 3 Interventions

Group IV: Phase 1 Received T-cell engager (TCE) therapy (Cohort 4) Experimental Treatment 3 Interventions

Group V: Phase 1 CAR T naïve (Cohort 1) Experimental Treatment 3 Interventions

Group VI: Phase 1 CAR T experienced (Cohort 2) Experimental Treatment 3 Interventions

IMPT-314 is already approved in United States for the following indications:

Approved in United States as IMPT-314 for:

• Relapsed or refractory aggressive B-cell lymphoma
• High-grade B-cell lymphoma (HGBCL)
• Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)
• Primary mediastinal B-cell lymphoma
• DLBCL arising from follicular lymphoma

Who Is Running the Clinical Trial?

Lyell Immunopharma, Inc.

Lead Sponsor

Trials

5

Recruited

610+

ImmPACT Bio

Lead Sponsor

Trials

2

Recruited

150+