Afrin Firfiray

Enabling access to talicabtagene autoleucel in relapsed/refractory B-cell malignancies; multicenter real-world evidence on delivery, efficacy and safety

Atharva Karulkar, Hasmukh Jain, Neeraj Sidharthan, Dinesh Bhurani et autres

Talicabtagene autoleucel (tali-cel) is the first humanized CD19-directed CAR-T cell therapy approved in India for relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). Here, we integrated clinical and manufacturing operations through a centralized coordination unit (CCU) and evaluated …

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Tali-cel is a safe and effective therapy in patients with Relapsed/Refractory B-cell non-Hodgkin lymphoma that allows equitable access- a real-world experience from India.

Hasmukh Jain, Atharva Karulkar, Devanshi Kalra, Smrithi Ravikumar et autres

Abstract Background : Talicabtagene autoleucel (Tali-cel), a second-generation, humanized CAR-T cell therapy targeting CD19, was approved in India in October 2023 for the treatment of relapsed or refractory (r/r) B-cell malignancies. This report presents real-world data on its clinical effectiveness, safety profile, …

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Early use of talicabtagene autoleucel in r/r B-acute lymphoblastic leukemia is cost-effective: Improved efficacy, reduced toxicity and healthcare resource utilization support affordable access

Atharva Karulkar, Hasmukh Jain, Devanshi Kalra, Smrithi Ravikumar et autres

Abstract Background: In India, access to curative therapies for relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) remains limited due to restricted availability of allogeneic transplants and monoclonal antibodies. Talicabtagene autoleucel (Tali-cel), a CD19-directed humanized CAR-T cell therapy, was recently approved as the …

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A multicentre Phase I clinical trial demonstrates manufacturing feasibility, safety and activity of novel humanized BCMA-directed CAR-T cell therapy.

Manju Sengar, Ashish Saroha, Atharva Karulkar, Devanshi Kalra et autres

Abstract Background: BCMA directed CAR-T cell therapies have shown durable responses and improved outcomes in relapsed/refractory multiple myeloma (RRMM). We designed and developed novel humanized BCMA-directed CAR-T cell therapy (hBCMA) with robust activity and low toxicities in preclinical settings (Khan et al., …

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Development of equitable access model for nationwide implementation of affordable CAR-T cell therapy in India: a real-world experience.

Atharva Karulkar, Arindam Banik, Dipak Kalra, S Ravikumar et autres

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Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: results from an open-label, multicentre, phase 1/2 study

Hasmukh Jain, Atharva Karulkar, Devanshi Kalra, Smrithi Ravikumar et autres

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Development of a Novel Humanized BCMA-Directed CAR for Multiple Myeloma: Robust Activity and Low Toxicity in Preclinical Studies

Aalia N. Khan, Jayant Sastri Goda, Sweety Asija, Atharva Karulkar et autres

Background: Chimeric antigen receptor T (CAR-T) cell therapies targeting B cell maturation antigen (BCMA) have emerged as a promising intervention for relapsed/refractory multiple myeloma (r/r MM). However, challenges such as treatment-related inflammatory toxicities [cytokine release syndrome (CRS) and neurotoxicity], relapse, limited availability, …

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Talicabtagene Autoleucel (humanized CD19 CAR-T) As a Second Line Therapy in r/r B-Cell Lymphoma: Sub-Analysis from a Phase I/II Trial

Hasmukh Jain, Atharva Karulkar, Ankesh Kumar Jaiswal, Devanshi Kalra et autres

Background: CAR-T cell therapy is effective and used in the second line treatment of relapsed/refractory B-cell lymphoma. However, costs of delivery remain high due to the manufacturing costs and toxicity management requiring specialized care. CARs with lower toxicity profile can improve access …

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Real World Data of Novel Talicabtagene Autoleucel (humanized CD19 CAR-T) from India; Ensuring Equitable Access with Excellent Safety and Efficacy Profile

Hasmukh Jain, Atharva Karulkar, Devanshi Kalra, Smrithi Ravikumar et autres

Background: Talicabtagene autoleucel (Tali-cel), (formerly Actalycabtagene autoleucel) is a humanized anti-CD19 CAR-T cell therapy, approved by the CDSCO (Indian regulatory agency) in October 2023 based on its efficacy and safety data (ASH 2022, 2023). Since its approval, several centers across India have …

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An Analysis of Infectious Complications Post-Treatment With Actalycabtagene Autoleucel

Hasmukh Jain, Rohan Verghese, Raveendra MV, Atharva Karulkar et autres

CT-643 An Analysis of Infectious Complications Post-Treatment With Actalycabtagene Autoleucel

Hasmukh Jain, Rohan Verghese, Raveendra MV, Atharva Karulkar et autres

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Evaluating the Safety of HCAR19 (Now Actalycabtagene Autoleucel- Actaly-Cel™), a Novel Humanized CD19-Directed Chimeric Antigen Receptor T-Cells in Pediatric, Adolescents, and Young Adults with Relapsed/ Refractory B- Acute Lymphoblastic Leukemia (ESHA) - Report of Phase-1B

Gaurav Narula, Swaminathan Keerthivasagam, Hasmukh Jain, Chetan Anil Dhamne et autres

Background and aims Chimeric Antigen Receptor (CAR) T-cell therapies for relapsed-refractory Pediatric B-cell Acute Lymphoblastic Leukemia (r/r-B-ALL) show remarkable success but remain prohibitively expensive. We developed and reported a Humanized CD19-directed novel CAR T-cell- HCAR19 (now -Actalycabtagene autoleucel- Actaly-cel™) with robust activity …

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