Transplantation & Cellular Therapy
The latest news, research, and perspectives in transplantation and cellular therapy. Autologous and allogeneic hematopoietic stem cell transplantation represent potentially curative options for some patients, while the field of non-transplant cellular therapies, such as chimeric antigen receptor (CAR) T-cell therapies, CAR natural killer cell therapies, and genetically modified T-cell receptors, is also expanding to offer more patients curative options.
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The positive opinion is based on results from the phase II TRANSCEND FL study, in which liso-cel showed an ORR of 97.1%.
This new indication for the injection alkylating agent pertains to adult or pediatric patients aged one year and older.
The therapies are under development for EBV-positive PTLD, non-Hodgkin lymphoma, and systemic lupus erythematosus.
The CRL is related to observations of a third-party manufacturing facility as part of a standard prelicense inspection.
The first-of-its-type anti-CSF-1R antibody is approved for use in adult and pediatric patients who weigh at least 40 kg.
Patient-reported outcomes of the CARTITUDE-4 trial showed an improvement in quality of life with cilta-cel versus SOC.
CAR-T achieves favorable responses and survival in relapsed or refractory LBCL in both the second- and third-line setting.
The therapy under evaluation by two ongoing studies involves a new accelerated CAR T-cell product manufacturing process.
The 5-year follow-up analysis of ZUMA-5 showed continued efficacy and no new safety signals.
The phase 1b study of CAR22 is ongoing, and investigators are currently looking to enroll more patients.
Dr. Matthew Cortese reported that CAR T-cell therapy appears to overcome some of the adverse prognostic impact.
The study used a standard 3+3 dose escalation design to evaluate the results of SYNCAR-001 plus STK-009.
Data support rituximab over watchful waiting in front-line therapy for low-tumor-burden follicular lymphoma, study concludes.
A compound to assist CAR T-cell therapy by targeting and suppressing YTHDF2 is in development.
A new investigator-initiated trial in China will investigate KJ-C2219 for relapsed or refractory B-cell non-Hodgkin lymphoma.
Approval was granted by the FDA on the basis of findings from the phase 3 MSB-GVHD001 clinical trial.
Limitations on benefits from immunotherapy in this setting increase clinical interest in this CAR T-cell therapy approach.
The approach demonstrated safety and produced response in B-ALL, DLBCL, follicular lymphoma, and MCL.
Encouraging initial study findings in mice will inform the design of a BHB supplementation trial in human patients.
A large, multicenter retrospective study found favorable efficacy and toxicity with this approach.
Odronextamab monotherapy showed promising efficacy in patients with high-risk, grade 1-3a follicular lymphoma.
Robust responses with favorable safety has been demonstrated with tisagenlecleucel in relapsed or refractory Fl.
Favorable preclinical outcomes were demonstrated with VX765 treatment.
Upfront treatment with fixed-duration subcutaneous mosunetuzumab demonstrated a high complete response rate in FL and MZL.
Phase 1 study results hint response durability for novel CAR-T agent, CAR22 in certain patients with large B-cell lymphoma.
Molecular features typically associated with inferior outcomes did not significantly affect survival or CAR-T response.
Liso-cel plus ibrutinib demonstrates substantial efficacy, deep remissions, and manageable safety.
Although liso-cel has a higher total cost than mosunetuzumab, it provides increased survival and reduced time toxicity.
Patients treated with tisa-cel, axi-cel, or liso-cel had an ORR of 65% and a one-month CR rate of 46%.
A study has compared responses with anti-CD19 CAR-T therapy in MCL with and without active CNS involvement at infusion.
An MAIC analysis of data from clinical trials identified differences in efficacy and safety between the two interventions.
The authors found the complete response rate results to be promising and to warrant further clinical investigation.
Bilal Abid, MD, describes how to approach sequencing pirtobrutinib after CAR-T therapy.
Dr. Abid describes when he uses bispecifics versus CAR-T in his practice at the University of Texas Health Science Center.
Encouraging efficacy and safety seen over 17 months in a phase II trial continued into the trial's 29-month follow-up period.
In a retrospective study bendamustine compared favorably with the cyclophosphamide plus fludarabine lymphodepletion regimen.
A first ever phase I/II trial tested escalating doses in patients with relapsed or refractory disease.
Axi-cel produced sustained long-term responses in patients with follicular lymphoma and marginal zone lymphoma.
A phase II trial found antitumor effect across patient subgroups and independently of risk factors for disease progression.
Treatment with liso-cel was effective and safe in patients with relapsed or refractory follicular lymphoma in TRANSCEND FL.
Manali Kamdar, MD, shared results from the pivotal phase III TRANSFORM study on lisocabtagene maraleucel in LBCL.
Patients with relapsed refractory LBCL can derive clinical benefit from liso-cel NCP without compromising safety.
The median progression-free survival, duration of response, and overall survival were not reached.
Benefits of CAR T-cell therapy outweigh the hypothetical future risk of secondary malignancies.
In approximately 12,000 reports of adverse events, the researchers found 19 cases of T-cell malignancies after CAR-T.
The investigators reviewed case reports of patients 20 years old and younger who underwent therapy for BPDCN.
HMA plus venetoclax was found to be effective and well tolerated in patients with AML who relapsed after HSCT.
Adding ofatumumab to reduced intensity conditioning is safe and effective in high-risk B-cell non-Hodgkin lymphoma.
The study also explored the role of this combination in transitioning patients to HSCT.
The award grants $100,000 to a postdoctoral or early-career oncology researcher from a racial/ethnic minority group.
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