IMPT-314 for Non-Hodgkin's Lymphoma

Recruiting at20 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Lyell Immunopharma, Inc.

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Active CNS involvement, Cardiac lymphoma, others

No Placebo Group

Approved in 1 Jurisdiction

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 IMPT-314, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive B-cell NHL. Three cohorts of participants will be enrolled: 1) CAR T naïve after at least two or more prior lines of treatment, 2) CAR T experienced and 3) refractory disease or relapse within one year of first line therapy. Up to approximately 90 patients (30 per cohort) will be enrolled in dose finding Phase 1 part of the study, which will determine the recommended phase 2 dose. Phase 2 will enroll up to approximately 60 additional participants (20 per cohort) to evaluate further the safety and efficacy of IMPT-314. IMPT-314 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days. Individual participants will remain in the active post-treatment period for approximately 2 years. Participants will continue in long-term follow-up for 15 years from treatment.

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.

Research Team

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.

Trial 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 (CAR T-cell Therapy)

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 II Refractory disease or relapse within one year of first line therapy Experimental Treatment 1 Intervention

Single dose determined during Phase I.

Group II: Phase II CAR T naïve cohort Experimental Treatment 1 Intervention

Single dose determined during Phase I.

Group III: Phase II CAR T experienced cohort Experimental Treatment 1 Intervention

Single dose determined during Phase I.

Group IV: Phase I Dose Level II Refractory disease or relapse within one year of first line therapy Experimental Treatment 1 Intervention

Phase I 3+3 design Dose level 2: 3×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window

Group V: Phase I Dose Level II CAR T naïve cohort Experimental Treatment 1 Intervention

Phase I 3+3 design Dose level 2: 3×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window

Group VI: Phase I Dose Level II CAR T experienced cohort Experimental Treatment 1 Intervention

Phase I 3+3 design Dose level 2: 3×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window

Group VII: Phase I Dose Level I Refractory disease or relapse within one year of first line therapy Experimental Treatment 1 Intervention

Phase I 3+3 design Dose level 1: 1×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window

Group VIII: Phase I Dose Level I CAR T naïve cohort Experimental Treatment 1 Intervention

Phase I 3+3 design Dose level 1: 1×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window

Group IX: Phase I Dose Level I CAR T experienced cohort Experimental Treatment 1 Intervention

Phase I 3+3 design Dose level 1: 1×10e8 (± 20%) IMPT-314 cells Single dose/infusion during 28 day window

Who Is Running the Clinical Trial?

Lyell Immunopharma, Inc.

Lead Sponsor

Trials

5

Recruited

610+

ImmPACT Bio

Lead Sponsor

Trials

2

Recruited

150+