A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

Evaluate safety and tolerability of SC291

Secondary Objectives:

Evaluate preliminary anti-tumor activity of SC291

Evaluate cellular kinetics and persistence of SC291

Cellular kinetics (CK)-related parameters evaluated by CAR copy number (CAR VCN): peak observed in peripheral blood after administration (Cmax), time of first occurrence of maximum-observed concentration (Tmax), terminal disposition phase half-life (t1/2), last observed quantifiable concentration in peripheral blood (Clast), time of last observed quantifiable concentration in peripheral blood (days) (Tlast), area under the concentration-time curves (AUCs)

Evaluate host immunogenicity to SC291

Eligibility

Inclusion Criteria:

Male or female subjects aged 18-80 years at the time of signing informed consent.
Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including:
Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise - specified (including DLBCL arising from indolent lymphoma), primary mediastinal large -- - B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B
Follicular lymphoma (dose escalation only except for follicular lymphoma grade 3B)
Marginal zone lymphoma (dose escalation only)
Mantle cell lymphoma (dose escalation only)
CLL or SLL
Relapsed/refractory disease after at least 2 prior systemic regimens per standard of care or after autologous stem cell transplant
ECOG performance status of 0 or 1.
At least one measurable lesion per Lugano Classification (NHL); CLL subjects must meet iwCLL treatment criteria
Life expectancy ≥12 weeks

Exclusion Criteria:

Prior anti-CD19 therapy including CD19-directed CAR T treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only - prior approved CD19-directed CAR T therapy required)
History of primary central nervous system (CNS) lymphoma or presence of CNS metastases
Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) or radiotherapy within 14 days of SC291 (28 days for biologics)
Autologous HSCT within 6 weeks of treatment with SC291 (or allogeneic HSCT at any time).
Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >20 mg/day prednisone or equivalent).
History or presence of cardiac or CNS disorders as defined in the protocol

Locations

4100 John R
Detroit, MI 48201
Get Directions

Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions

Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices