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DRUG:

bbT369

i
Other names: bbT369, bbT 369, bbT-369
Associations
Company:
Regeneron
Drug class:
CD20-targeted CAR-T immunotherapy, CD79a-targeted CAR-T immunotherapy
Associations
8ms
CRC-403: A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov)
P1/2, N=50, Recruiting, 2seventy bio | Trial primary completion date: Dec 2023 --> Aug 2024
Trial primary completion date • CAR T-Cell Therapy
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BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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BCL6 rearrangement • BCL2 rearrangement
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bbT369
over1year
bbT369, a Clinical-Stage Dual-Targeted and CBLB Gene Edited Autologous CAR T Product for Non-Hodgkin Lymphoma, Shows Edit Driven Enhanced Activity in Preclinical In Vitro and In Vivo Models (ASGCT 2023)
In addition, we show that bbT369 T cells drive greater T cell expansion and durable tumor control compared with unedited controls in vivo using a xenograft NSG mouse model. Collectively, the data support the potential for bbT369 to provide deeper and more durable responses in NHL patients including those with more challenging disease characteristics.
Preclinical • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CBL (Cbl proto-oncogene) • CD79A (CD79a Molecule) • TGFB1 (Transforming Growth Factor Beta 1) • CBLB (Cbl Proto-Oncogene B)
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CD20 expression
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bbT369
almost2years
CRC-403: A Phase 1/2 Study of bbT369, a Dual CD79a and CD20 Targeting CAR T Cell Drug Product with a Gene Edit, in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (ASH 2022)
The starting dose of bbT369 is 50x106 CAR+ T cells and a BOIN design is being used for dose escalation/de-escalation decisions during the study. Upon establishment of the RP2D, the phase 2 portion will begin enrollment.
P1/2 data • CAR T-Cell Therapy
|
CD19 (CD19 Molecule) • CD79A (CD79a Molecule)
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bbT369
over2years
bbT369, a dual-targeted and CBLB gene-edited autologous CART product, demonstrates anti-lymphoma activity in preclinical mouse models (AACR 2022)
Furthermore, while a fraction of mice (3/5) receiving the unedited anti-CD79a/CD20 dual-targeting CAR T cells experienced late relapses (between 60-80 days following initial tumor clearance), all mice (n=5) receiving bbT369 were fully protected from late relapses (up to day 104 of follow-up). Collectively, the data support a first-in-human trial for bbT369 to evaluate initial safety and efficacy in NHL patients.
Preclinical • IO biomarker
|
CBL (Cbl proto-oncogene)
|
CD20 expression
|
bbT369
over2years
A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov)
P1/2, N=50, Recruiting, 2seventy bio | Not yet recruiting --> Recruiting
Enrollment open • CAR T-Cell Therapy
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
BCL6 rearrangement • BCL2 rearrangement
|
bbT369
almost3years
New P1/2 trial • CAR T-Cell Therapy
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
BCL6 rearrangement • BCL2 rearrangement
|
bbT369