BOB1-TCR therapy for treatment of relapsed or refractory B-cell malignancies - A Phase 1/2 clinical trial

Conditions

B-cell Acute Lymphoblastic Leukemia, Multiple Myeloma, Non-Hodgkin B-cell lymphoma

Brief summary

Phase 1: The proportion of manufacturing runs from which a LUMCBOB1-B7-TCR.1 drug product was generated at the intended dose., Phase 1: The proportion of included patients that received LUMC-BOB1- B7-TCR.1 treatment., Phase 1: The rate of dose-limiting toxicities (DLTs) within a specific dose cohort until 28 days after LUMC-BOB1-B7-TCR.1 infusion., Phase 1: The maximum tolerated dose evaluated by Bayesian Dose Interval (BOIN) design with a target toxicity rate of 0.3, which is defined as the rate of DLTs within a dose cohort until 28 days after LUMC-BOB1-B7- TCR.1 infusion., Phase 1: The recommended dose for patient treatment in phase 2., Phase 2: Safety and toxicity assessment of LUMC-BOB1-B7-TCR.1 treatment per (serious) adverse event (AE) up to 2 years after infusion, reported according to ASTCT and CTCAE., Phase 2: Response rate 12 weeks after infusion, response is defined as absence of circulating B cells and/or best objective response as defined in literature.

Related papers

No related papers found yet.

Interventions

DRUGLUMC-BOB1-B7-TCR.1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1: The proportion of manufacturing runs from which a LUMCBOB1-B7-TCR.1 drug product was generated at the intended dose., Phase 1: The proportion of included patients that received LUMC-BOB1- B7-TCR.1 treatment., Phase 1: The rate of dose-limiting toxicities (DLTs) within a specific dose cohort until 28 days after LUMC-BOB1-B7-TCR.1 infusion., Phase 1: The maximum tolerated dose evaluated by Bayesian Dose Interval (BOIN) design with a target toxicity rate of 0.3, which is defined as the rate of DLTs within a dose cohort until 28 days after LUMC-BOB1-B7- TCR.1 infusion., Phase 1: The recommended dose for patient treatment in phase 2., Phase 2: Safety and toxicity assessment of LUMC-BOB1-B7-TCR.1 treatment per (serious) adverse event (AE) up to 2 years after infusion, reported according to ASTCT and CTCAE., Phase 2: Response rate 12 weeks after infusion, response is defined as absence of circulating B cells and/or best objective response as defined in literature.	—

Measure

Time frame

Phase 1: The proportion of manufacturing runs from which a LUMCBOB1-B7-TCR.1 drug product was generated at the intended dose., Phase 1: The proportion of included patients that received LUMC-BOB1- B7-TCR.1 treatment., Phase 1: The rate of dose-limiting toxicities (DLTs) within a specific dose cohort until 28 days after LUMC-BOB1-B7-TCR.1 infusion., Phase 1: The maximum tolerated dose evaluated by Bayesian Dose Interval (BOIN) design with a target toxicity rate of 0.3, which is defined as the rate of DLTs within a dose cohort until 28 days after LUMC-BOB1-B7- TCR.1 infusion., Phase 1: The recommended dose for patient treatment in phase 2., Phase 2: Safety and toxicity assessment of LUMC-BOB1-B7-TCR.1 treatment per (serious) adverse event (AE) up to 2 years after infusion, reported according to ASTCT and CTCAE., Phase 2: Response rate 12 weeks after infusion, response is defined as absence of circulating B cells and/or best objective response as defined in literature.

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Countries

Netherlands

Outcome results

None listed