A Phase 1b/2 Trial of Hu5F9-G4 in Combination with Rituximab or with Rituximab + Chemotherapy in Patients with Relapsed/Refractory B cell Non Hodgkin s Lymphoma

NOT ENROLLING
Protocol # :
17-313
Conditions
Non Hodgkin Lymphoma
Phase
II
Disease Sites
Other Hematopoietic
Non-Hodgkin's Lymphoma
Principal Investigator
Lacasce, Ann, S.
Site Investigator
Arnason, Jon
Site Research Nurses
Aiken, Haley
Babcock, Elise
Brennan, Lisa
Bright, Susan
Coleman, Kimberly, C.
Francoeur, Karen
Green, Mallory
Guy-Hamilton, Rebecca
Kilcommons, Marykate
Knudsen, Elisabeth
Marzullo, Tess, V.
McDermott, Kathleen
Normilus, Samantha
Patterson, Victoria
Tichon, Jennifer

Trial Description

The primary objectives of this study are:

- To investigate the safety and tolerability, and to define the recommended Phase 2 dose
and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in
combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx).

- To evaluate the efficacy of magrolimab in combination with rituximab in participants
with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the
efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant
(ASCT) ineligible DLBCL participants.

Eligibility Requirements

Key Inclusion Criteria:

- Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard
approved therapies

- DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL)
expressing CD 20, relapsed or refractory to at least 2 prior lines treatment
containing anti-CD20 therapy

- Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or
refractory to standard approved therapies

- DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell
lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment

- Adequate performance status and hematological, liver and kidney functions

- Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy

Key Exclusion Criteria:

- Active brain metastases

- Prior allogeneic hematopoietic cell transplantation

- Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents

- Second malignancy within the last 3 years

- Known active or chronic hepatitis B or C infection or HIV

- Pregnancy or active breastfeeding

- Prior chimeric antigen receptor (CAR-T) therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

17-313