Allogeneic NK Cell Therapy for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Gamida Cell ltd

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is an open-label, non-randomized, interventional, single group assignment study of GDA-201, an allogeneic cryopreserved Natural Killer (NK) cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).

Research Team

Eligibility Criteria

This trial is for adults with B Cell non-Hodgkin lymphoma that hasn't improved after at least two treatments. They must be in good health otherwise, not have had certain cell therapies or transplants recently, and can't join if they have cancer affecting the brain.

Inclusion Criteria

I am 18 years old or older.

My FL or DLBCL cancer has not responded to at least 2 previous treatments.

I had a stem cell transplant using my own cells less than 3 months ago.

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Exclusion Criteria

I have lymphoma in my central nervous system.

Treatment Details

Interventions

GDA-201 (NK Cell Therapy)

Trial OverviewThe study tests GDA-201 NK cells combined with rituximab in patients whose lymphoma has returned or didn't respond to treatment. It's an early-phase trial where everyone gets the same therapy to see how safe it is and if it works.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: GDA-201 Cohort 2 (Phase II)Experimental Treatment1 Intervention

RP2D will be administered to all patients.

Group II: GDA-201 Cohort 1 (Phase I)Experimental Treatment1 Intervention

Dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D).