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Doses from 0.3 to 45 µg/dose by intravenous infusion

CC312

ZHEN JING, MM

JUNYUAN QI, MD

This is a Phase 1, open-label, dose-escalation study to evaluate the safety, PK, PD and immunogenicity of CC312 following intravenous doses of CC312 in patients with relapsed and refractory (r/r) CD19 expressing B-cell non-Hodgkin lymphoma and B-cell lymphocytic leukemia.

This study is an accelerated dose titration design divided into 2 parts.

Part 1 of the study is an accelerated dose-escalation design involving 5 dose levels: 0.3, 0.6, 1.2, 2.4 and 4.8 mcg given intravenously (IV) with cohorts of one patient per dose level. Patients in this part will receive 1 priming dose (D-7) and 1 intermediate dose of CC312 (D-3) on the first week, followed by twice weekly dosing of escalated dose for three weeks beginning on the second week. The dose limiting toxicity (DLT) observation period will be 28 days. The optimal priming dose and intermediate dose level will be determined in this part.

Part 2-A will follow a standard 3 + 3 dose escalation design using five dose levels: 9.6, 16, 24, 34 and 45 μg to obtain data on the safety and tolerability of CC312. Patients in this part will receive priming dose and intermediate dose of CC312 established in Part 1 before given the treatment dose. MTD or RP2D will be determined in Part 2-A and tested in expanded population(Part 2-B).

Part 2-B is planned for cohorts of 6-10 patients with B-cell non-Hodgkin lymphoma or B-cell lymphocytic leukemia receiving priming/ treatment dose levels as defined in the Part 1 and Part 2-A study.

Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies

B-NHL, B-ALL and CLL will be evaluated by Lugano criteria, NCCN Guidelines 2021, and iwCLL guidelines 2008, respectively. Therapeutic endpoints includes: overall response rate \[ORR\] (including complete remission \[CR\] and partial remission \[PR\]), duration of overall response \[DOR\], disease control rate \[DCR\], and relapse-free survival \[RFS\] in participants.

Toxicity will be evaluated according to the NCI CTCAE, Version 5.0, except CRS which will be graded according to ASTCT Consensus Grading for CRS.

Overall numbers of participants with any AE, including any laboratory abnormality, treatment-emergent adverse event (TEAE), and serious adverse events (SAE). Severity (toxicity grade) for each AE will be determined using the NCI CTCAE, version 5.0; except cytokine release syndrom (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) which will be graded according to ASTCT Consensus Grading.

Blood samples will be collected to analysis serum concentration of CC312. Derived PK parameters will be calculated using the non-compartmental model.

Peripheral blood will be collected for CRS-related cytokine analysis in all dose escalation cohorts.

Peripheral blood will be collected for immunophenotyping (including the activation of CD4+ and CD8+ T cells, and depletion of B cells) in all dose escalation cohorts.

The proportions of participants with positive anti-drug antibody (ADA) status and those with positive neutralizing anti-drug antibody (NAb) status will be presented by descriptive statistics.

Spots Global Cancer Trial Database for cc312

Every month we try and update this database with for cc312 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cc312

Every month we try and update this database with for cc312 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cc312 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.