Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rhuFlt3L/CDX-301 · 1 trial · 1 indication
Overall objective response rate at time of best response as defined by International Harmonization (Cheson) Criteria.
| Arm | Type | Description |
|---|---|---|
| rhuFlt3L/CDX-301 | EXPERIMENTAL | intratumoral injections on days 1-5 and 8-11. and Poly-ICLC intratumoral injection weekly, weeks 2-8 |
| Name | Type | Description |
|---|---|---|
| rhuFlt3L/CDX-301 | DRUG | rhuFlt3L/CDX-301 is a truncated, soluble, recombinant human fms-like tyrosine kinase-3 ligand (Flt3L), expressed in a Chinese hamster ovary cell. RhuFlt3L/CDX-301 is formulated as a sterile solution intended for single-use parenteral administration. Each vial contains 2.5 mg/mL rhuFlt3L/CDX-301 in a 1 mL of buffered solution composed of Sodium Phosphate and Sodium Chloride, with a pH of 7. |
| Poly-ICLC | DRUG | Poly-ICLC is supplied by Oncovir in single-dose vials containing 1 mL of 2 mg/mL opalescent white suspension. Each milliliter of Poly-ICLC for injection contains 2 mg/mL poly-IC, 1.5 mg/mL poly-L-lysine, and 5 mg/mL sodium carboxymethylcellulose in 0.9% sodium chloride solution and adjusted to pH 7.6-7.8 with sodium hydroxide. |
Inclusion Criteria: * Biopsy-confirmed low-grade B-cell lymphoma or cutaneous T cell lymphoma; specifically, follicular grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma, or mycosis fungoides of any initial stage. Patients in cohort A must be relapsed/refractory after at least one prio...
rhuFlt3L/CDX-301 is an investigational oncology agent developed by Celldex Therapeutics, Inc. (ticker CLDX). It was studied in a Phase 1 trial as part of an in situ vaccine approach for low-grade B-cell lymphoma, combining intratumoral Flt3L with Poly-ICLC and low-dose radiotherapy. It is not an approved therapy.
rhuFlt3L/CDX-301 was studied for low-grade B-cell lymphoma. The single Phase 1 trial evaluated it as an in situ vaccine combined with Poly-ICLC and low-dose radiotherapy in patients with this condition. The trial has completed, and the agent remains investigational rather than an approved treatment.
Celldex Therapeutics, Inc., which trades under the ticker CLDX, is the developer of rhuFlt3L/CDX-301. The company sponsored the Phase 1 study of the agent in low-grade B-cell lymphoma conducted in the United States.
rhuFlt3L/CDX-301 is in Phase 1 development. Its only recorded clinical trial, NCT01976585, was a Phase 1 study that has completed. The agent is investigational and has not been approved for any indication.
rhuFlt3L/CDX-301 was evaluated in one clinical trial, NCT01976585, titled In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy. The Phase 1 study enrolled 21 participants in the United States and has completed. No active trials are ongoing.
Yes, rhuFlt3L/CDX-301 is also known as CDX-301. Both names refer to the same Celldex Therapeutics agent that was studied in the completed Phase 1 trial NCT01976585 for low-grade B-cell lymphoma.