Patients with lower-risk (LR) myelodysplastic syndromes (MDS) who are RBC transfusion dependent and have experienced relapse after or are refractory to erythropoiesis-stimulating agent (ESA) have ...limited treatment options. High telomerase activity and human telomerase reverse-transcription expression in clonal hematopoietic cells have been reported in patients with MDS. Imetelstat, a first-in-class competitive inhibitor of telomerase enzymatic activity, targets cells with active telomerase. We report efficacy, safety, and biomarker data for patients with LR MDS who are RBC transfusion dependent and who were relapsed/refractory to ESAs.
In this two-part phase II/III study (MDS3001), the primary end point was 8-week RBC transfusion independence (TI) rate, with key secondary end points of 24-week RBC TI rate, TI duration, and hematologic improvement-erythroid.
Data from the phase II part of the study are reported. Of 57 patients enrolled and treated (overall population), 38 were non-del(5q) and hypomethylating agent and lenalidomide naïve (subset population). The 8- and 24-week RBC TI rates in the overall population were 37% and 23%, respectively, with a median TI duration of 65 weeks. In the subset population, 8- and 24-week RBC TI rates were 42% and 29%, respectively, with a median TI duration of 86 weeks. Eight-week TI rate was observed across all subgroups evaluated. Cytogenetic and mutational data revealed a reduction of the malignant clones, suggesting disease modification activity. The most common adverse events were cytopenias, typically reversible within 4 weeks.
Imetelstat treatment results in a meaningful, durable TI rate across a broad range of heavily transfused patients with LR MDS who are ineligible for or relapsed/refractory to ESAs. Biomarker analyses indicated effects on the mutant malignant clone.
•Cilta-cel, a BCMA-targeting chimeric antigen receptor−T-cell therapy, induced clinical responses in patients previously exposed to noncellular anti-BCMA therapies.•Results of this study may inform ...sequencing strategies for anti-BCMA therapies in patients with relapsed/refractory MM.
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B-cell maturation antigen (BCMA)–targeting therapies, including bispecific antibodies (BsAbs) and antibody-drug conjugates (ADCs), are promising treatments for multiple myeloma (MM), but disease may progress after their use. CARTITUDE-2 is a phase 2, multicohort study evaluating the safety and efficacy of cilta-cel, an anti-BCMA chimeric antigen receptor T therapy, in various myeloma patient populations. Patients in cohort C progressed despite treatment with a proteasome inhibitor, immunomodulatory drug, anti-CD38 antibody, and noncellular anti-BCMA immunotherapy. A single cilta-cel infusion was given after lymphodepletion. The primary end point was minimal residual disease (MRD) negativity at 10−5. Overall, 20 patients were treated (13 ADC exposed; 7 BsAb exposed; 1 in the ADC group also had prior BsAb exposure). Sixteen (80%) were refractory to prior anti-BCMA therapy. At a median follow-up of 11.3 months (range, 0.6-16.0), 7 of 20 (35%) patients were MRD negative (7 of 10 70.0% in the MRD-evaluable subset). Overall response rate (95% confidence interval CI) was 60.0% (36.1-80.9). Median duration of response and progression-free survival (95% CI) were 11.5 (7.9—not estimable) and 9.1 (1.5—not estimable) months, respectively. The most common adverse events were hematologic. Cytokine release syndrome occurred in 12 (60%) patients (all grade 1-2); 4 had immune effector cell-associated neurotoxicity syndrome (2 had grade 3-4); none had parkinsonism. Seven (35%) patients died (3 of progressive disease, 4 of adverse events 1 treatment related, 3 unrelated). Cilta-cel induced favorable responses in patients with relapsed/refractory MM and prior exposure to anti-BCMA treatment who had exhausted other therapies. This trial was registered at www.clinicaltrials.gov as NCT04133636.
B-cell maturation antigen (BCMA) is the target for multiple, new therapeutics in relapsed multiple myeloma (MM). Cohen and colleagues begin to address the question of sequencing by reporting a small series of patients treated with anti-BCMA chimeric antigen receptor (CAR) T cells after failure of anti-BCMA antibody-based biologicals. The authors report responses in 60% of patients and highlight the need for larger studies in this setting and a better understanding of the mechanisms of resistance to individual agents.
7535 Background: The phase 2 multicohort CARTITUDE-2 study is evaluating ciltacabtagene autoleucel (cilta-cel) in patients (pts) with MM across multiple settings. Cohort A is examining cilta-cel in ...earlier lines of treatment (tx; LOT) in pts with lenalidomide (len)-refractory multiple myeloma (MM). Initial results for cohort A (N=20; median follow-up, 30 mo) showed cilta-cel led to minimal residual disease negativity (MRD neg) at 10 –5 in 100% of pts with evaluable samples (n=17). ORR was 95% (19/20), median DOR was not reached (NR), and the 24-mo PFS rate was 75%. We report protocol-specified results for the expansion subgroup. Methods: Pts with len-refractory MM after 1–3 LOT, including a PI and IMiD, and no anti-BCMA tx were enrolled. A single cilta-cel infusion (target dose, 0.75×10 6 range, 0.5–1.0×10 6 CAR+ viable T cells/kg) was given 5–7 d after the start of lymphodepletion. Cohort A initially evaluated cilta-cel manufactured by clinical trial processes and later expanded to evaluate cilta-cel manufactured by commercial processes. Primary endpoint was MRD neg at 10 –5 . Efficacy is reported for pts who received cilta-cel at target dose; demographics, baseline disease characteristics, and safety are reported for all treated pts in the expansion subgroup. Results: As of Sept 5, 2023, median follow-up was 16 mo. Of 24 pts enrolled, 23 received cilta-cel infusion (22 at target dose). Median age was 63 y, 52% were male, and 61% were triple-class exposed. Of 16 MRD-evaluable pts, 100% achieved MRD neg at 10 –5 ; median time to MRD neg was 2 mo (range, 1–12). ORR was 91% (20/22). Median DOR was NR; 79% of responders remained in response at 12 mo. Median (range) time to first and best responses were 1 mo (1–10) and 6 mo (1–19), respectively. 12-mo PFS and OS rates were 77% and 91%, respectively. All pts had TEAEs (grade gr 3/4, n=22; gr 5, n=1). Hematologic TEAEs included neutropenia (96%), leukopenia (65%), lymphopenia (65%), anemia (57%), and thrombocytopenia (57%). Infections occurred in 8 (35%) pts (gr 3/4, n=1; gr 5, n=1 due to sepsis). CRS occurred in 23 (100%) pts (gr 1/2, n=23); median time to onset was 8 d and recovery was 4 d. ICANS occurred in 4 (17%) pts (gr 1, n=3; gr 4, n=1); median time to onset was 10 d and recovery was 2 d. No other neurotoxicities or MNTs/parkinsonism occurred. 2 pts had secondary malignancies (SM); 1 pt had separate SM of gr 2 basal cell carcinoma and gr 2 squamous cell carcinoma and 1 pt had MDS diagnosed on d 846 that later transformed to AML. Per investigator assessment, SM were not tx-related. Conclusions: In the expansion subgroup of cohort A, cilta-cel led to deep and durable responses in pts with len-refractory MM as early as after first relapse; safety was consistent with the known mechanism of action of CAR-T tx. Results in the expansion and initial subgroups are comparable. Data for CARTITUDE-2 cohort A underscore observations in CARTITUDE-4 which enrolled a similar pt population. Clinical trial information: NCT04133636 .
7505 Background: CARTITUDE-2 is a phase 2 multicohort study evaluating ciltacabtagene autoleucel (cilta-cel) across various clinical settings. Cohort D is evaluating cilta-cel ± lenalidomide (len) ...maintenance in patients (pts) with newly diagnosed multiple myeloma (NDMM) who achieved less than complete response (CR) after autologous stem cell transplant (ASCT) frontline therapy (tx). We report efficacy and safety for this cohort. Methods: Adults with NDMM per IMWG criteria, best response of <CR and ≥stable disease after 4–8 cycles of initial tx, including induction, high-dose chemotherapy and ASCT ± consolidation, and without exposure to CAR-T or anti-BCMA tx received a single cilta-cel infusion (target dose, 0.75×10 6 CAR+ viable T cells/kg) 5–7 d after the start of lymphodepletion. Per protocol, safety was assessed in the first 5 pts with cilta-cel only; subsequently, 12 pts initiated continuous len maintenance ≥21 d post cilta-cel for ≤2 yrs. Primary endpoint was minimal residual disease negativity (MRD neg) at 10 –5 based on next-generation sequencing or flow. Results: As of Sept 5, 2023 (median follow-up, 22 mo range, 5–39), 17 pts received cilta-cel (with len, n=12; without len, n=5). Median age was 54 yrs; 6% had high-risk cytogenetics; and 100% were International Staging System stage I at baseline. Of 15 MRD-evaluable pts, 12 (80%) achieved MRD neg at 10 –5 ; median time to MRD neg was 1 mo (range, 1–6). Overall response rate was 94% (n=16/17; ≥CR, 94%). Median duration of response was not reached, and median time to first response was 1 mo. Progression-free survival (investigator-assessed) and overall survival rates at 18 mo were 94% each. CAR+ T cells peaked in blood at a median of 12 d post infusion (mean, 2187 cells/µL; SD, 2102 cells/µL) and remained detectable for a median of 43 d (range, 26–209). All pts had grade (gr) 3/4 TEAEs. Hematologic TEAEs included neutropenia (94%), lymphopenia (65%), thrombocytopenia (47%), and leukopenia (41%). Infections occurred in 12 (71%) pts (gr 3/4, 29%). CRS occurred in 14 (82%) pts, and median time to onset was 8 d. All CRS events were gr 1/2 and recovered in a median of 3 d. ICANS occurred in 1 pt (gr 1); median time to onset was 7 d and recovery was 1 d. Other neurotoxicities occurred in 6 pts (gr 1, n=1; gr 2, n=4; gr 3, n=1); median time to onset was 21 d and recovery was 70 d (n=4). No MNTs/parkinsonism occurred. 1 pt had a secondary malignancy of gr 3 MDS with an onset on d 353 that was not treatment related per investigator assessment. Conclusions: In pts with NDMM and <CR after frontline ASCT, a single cilta-cel infusion ± len maintenance demonstrated deep responses that were durable. TEAEs were consistent with the known safety profile of cilta-cel. These data show promising efficacy and safety with cilta-cel ± len maintenance in pts with NDMM who achieved <CR after ASCT frontline tx. Clinical trial information: NCT04133636 .
Introduction: Cilta-cel is a dual-binding, BCMA-targeting CAR-T cell therapy that has shown high rates of deep and durable response in patients (pts) with relapsed/refractory multiple myeloma (RRMM), ...and significantly prolonged PFS vs SOC in pts with lenalidomide-refractory MM after 1-3 prior lines of therapy (LOT; HR, 0.26) in the phase 3 CARTITUDE-4 trial. CAR-T therapies are associated with AEs related to immune activation, including neurologic toxicities (Gonzalez Castro. Neuro-Oncol Pract. 2020). Here, we describe the clinical experience with presentation and management of cranial neuropathy (CNP) in pts treated with cilta-cel in the CARTITUDE-1, CARTITUDE-2 Cohorts A, B, and C, and CARTITUDE-4 studies. Methods: CARTITUDE-1 and CARTITUDE-2 Cohort C pts had ≥3 prior LOT, incl PIs, IMiDs, and anti-CD38 mAbs, or were double-refractory to PI and IMiD; CARTITUDE-2 Cohort C pts also had non-cellular anti-BCMA therapy. CARTITUDE-2 Cohort B pts relapsed within 12 months of initial therapy. CARTITUDE-2 Cohort A and CARTITUDE-4 pts had 1-3 prior LOT, incl PI and IMiD, and were lenalidomide-refractory. After apheresis, pts received bridging therapy, then 1 cilta-cel infusion (target dose 0.75×10 6 CAR+ viable T cells/kg) 5-7 days (d) after lymphodepletion. Pts presenting with signs/symptoms of cranial nerve impairment commonly underwent a diagnostic workup that included CSF analysis and brain MRI at investigator discretion. Correlative data were available for pts in CARTITUDE-4: cilta-cel levels and T cell memory phenotypes in peripheral blood were assessed by flow cytometry, and serum cytokines were measured using multiplex sandwich immunoassays on the Meso Scale Discovery platform. Results: Of the 332 pts infused with cilta-cel as study treatment in CARTITUDE-1, CARTITUDE-2 (Cohorts A, B, and C), and CARTITUDE-4, 21 (6.3%) developed CNP (TABLE); most cases were grade (gr) 2 (n=3 gr 3). 6 pts had CNP that affected both sides; most unilateral impairments were left-sided. Median time to onset was 22 d (range 17-101; 81% had onset on d 22 +/- 5). Cranial nerve (CN) VII was involved in all pts; 2 pts had additional CNs involved (1 CN III gr 3, 2 CN V gr 3). Twelve pts had concurrent neurologic symptoms/neurotoxicities (headache, n=7; n=1 each for dysgeusia, parosmia, restlessness, peripheral sensory neuropathy, polyneuropathy, amnesia, aphasia, agitation, depressed level of consciousness). Clinical characteristics of pts with or without CNP were comparable. In the 21 pts with CNP, median age was 64 years; 81% were male; at baseline, 1 pt had high disease burden (BM 95% plasma cells), 4 had plasmacytomas (1 bone-based); 1 pt had ISS stage III. Most pts responded to bridging therapy. Six pts had an infection after cilta-cel infusion and prior to CNP onset (bacterial, n=5; CMV, n=2; both, n=1). CRS rate was comparable between pts with vs without CNP. 90% of pts with CNP had preceding CRS (all gr 1/2; median onset, d 7; median duration, 3 d); 13 received tocilizumab for CRS. One pt had preceding gr 2 ICANS; no pts had movement/neurocognitive TEAEs (MNT) at any time. CSF analysis and brain MRI were performed in 14 and 17 pts, respectively. No evidence of infectious or malignant etiology was identified in any of these cases; MRI showed facial nerve enhancement in 7 pts, in whom there were no other significant findings. Most CNP cases were treated with corticosteroids for median 13 d. CNP resolved in 19/21 pts within median 66 d, including the 3 pts with gr 3 CNP. In CARTITUDE-4, pts with CNP had significantly higher levels of CAR+ T cell expansion (C max) and greater exposure to CAR+ T cells (AUC 0-CNP onset) than those without CNP (FIGURE). Pts with CNP had a trend toward higher peak concentration and exposure level (AUC 0-CNP onset) of IL-6, IL-10, and IL-2Rα, but not in IFNγ. The differentiation pattern of memory T cells from apheresis to the time of peak CAR+ T expansion (T max) was comparable in pts with vs without CNP; CAR+ T cells at T max were dominant with central memory T cells in both groups. Conclusions:Ptstreated with CAR-T cells, including cilta-cel, may experience CNP.The pathogenesis of the events in these 3 studies was unknown/idiopathic, but it is important to rule out etiology of infection or MM progression. Most cases were low-grade and resolved with a limited course of corticosteroids. CNP in CARTITUDE-4 was associated with higher exposure to CAR-T cells before onset, but no predictive clinical factors have been established.
Introduction: CARTITUDE-2 (NCT04133636) is a phase 2, multicohort study evaluating the safety and efficacy of ciltacabtagene autoleucel (cilta-cel), an anti-BCMA chimeric antigen receptor (CAR)-T ...cell therapy, in various populations of patients with multiple myeloma (MM). We previously reported 17-month median follow-up results from cohort A (1-3 prior lines of therapy LOT and lenalidomide len-refractory) and 18-month median follow-up results from cohort B (early relapse: ≤12 months after either autologous stem cell transplant ASCT or start of initial anti-myeloma treatment, if not transplanted). Cilta-cel is also under evaluation in patients with len-refractory MM after 1-3 LOT in the phase 3 CARTITUDE-4 study, which showed cilta-cel significantly prolonged progression-free survival (PFS) vs standard of care (HR, 0.26) at a median follow-up of 16 months. Here, we present updated efficacy and safety data from CARTITUDE-2 cohorts A and B, both with a median follow-up of ~29 months. Methods: Patients in cohorts A and B, all naive to CAR-T and/or anti-BCMA therapies, received a single cilta-cel infusion (target dose 0.75×10 6 CAR+ viable T cells/kg) 5-7 days after lymphodepletion. In both cohorts, the primary endpoint was minimal residual disease (MRD)-negativity (10 -5 threshold, by next-generation sequencing or next-generation flow cytometry). Management strategies were implemented after the phase 1b/2 CARTITUDE-1 study to reduce risk of movement and neurocognitive treatment-emergent adverse events (MNTs). Results: As of April 2023, 20 patients in cohort A had received cilta-cel (median follow-up, 29.9 months; 35% with high-risk cytogenetics; median 2 prior LOT; 95% refractory to last LOT; 40% triple-class refractory; 85% with prior ASCT). At the same data cut-off, 19 patients in cohort B hadreceived cilta-cel (median follow-up, 27.9 months; 16% with high-risk cytogenetics; 79% refractory to last LOT; 16% triple-class refractory; 79% with prior ASCT). All (100%) 17 MRD-evaluable patients in cohort A and 14 (93%) of 15 MRD-evaluable patients in cohort B achieved MRD negativity (10 -5 threshold). Eight (40%) of 20 patients in cohort A and 10 (53%) of 19 patients in cohort B sustained MRD negativity at 10 -5 for ≥6 months (Table 1). In the 20 patients in cohort A and 19 in cohort B, cilta-cel led to overall response rates of 95% (complete response or better ≥CR, 90%) and 100% (≥CR, 90%), respectively. Median PFS was not reached in either cohort, and 24-month PFS rates were 75% in cohort A and 73% in cohort B; respective 24-month overall survival rates were 75% and 84%. In cohort A, hematologic treatment-emergent adverse events (TEAEs) occurring between 17.1- and 29.9-month median follow-up included maximum grade (gr) 3/4 leukopenia in 1 patient (all gr,12 total; 60%), maximum gr 3/4 lymphopenia in 2 patients (all gr,16 total; 80%), and maximum gr 3/4 thrombocytopenia in 1 patient (all gr,16 total; 80%). In cohort B, no new patients reported hematologic TEAEs between 18.0- and 27.9-month median follow-up (Table 2). In cohort A, no new patients had CAR-T cell neurotoxicity, and no patients had a second primary malignancy (SPM). In cohort B, no new patients had MNTs, but other neurotoxicity (gr 2 sensory loss) occurred in 1 additional patient (all gr, 5 total; 26%) and resolved; and SPM (gr 4 choroid melanoma) occurred in 1 additional patient (all gr, 2 total; 11%). One new death (total 5) occurred in cohort A on day 666 due to progressive disease, and 1 new death (total 4) occurred in cohort B on day 749 due to cardiac arrest (not treatment related). Conclusions: These longer-term follow-up data show that patients treated with cilta-cel in earlier LOT, both those with len-refractory MM after 1-3 LOT (cohort A) and those with early relapse (cohort B), experienced deep and durable responses. No new CAR-T-related safety signals, except for 1 additional CAR-T cell neurotoxicity in cohort B, were reported. Cohort A provides insight into potential longer-term survival outcomes that may be expected in the phase 3 CARTITUDE-4 trial, which enrolled the same patient population but has shorter follow-up thus far. The long-term cohort B data highlight the durable efficacy of cilta-cel in patients who had early relapse; this is a functionally high-risk population for whom standard risk factors, including a high-risk cytogenetic profile, may not predict risk of relapse and for whom there is significant unmet need.
8020
Background: Cohort A of the multicohort phase 2 CARTITUDE-2 (NCT04133636) study is evaluating cilta-cel safety and efficacy in pts with MM who received 1–3 prior LOT and were len-refractory – a ...difficult-to-treat population with poor prognosis. We present updated results. Methods: Pts had progressive MM after 1–3 prior LOT, including a PI and IMiD, were len-refractory, and had no prior exposure to BCMA-targeting agents. A single cilta-cel infusion (target dose 0.75×10
6
CAR+ viable T cells/kg) was given post lymphodepletion. Safety and efficacy were assessed, and the primary endpoint was MRD negativity at 10
-5
. Management strategies were implemented to minimize risk of movement/neurocognitive AEs (MNTs). Pharmacokinetic (PK) analyses (C
max
and T
max
of CAR+ T-cell transgene levels in blood) are being conducted, as well as analyses of levels of CRS-related cytokines (eg, IL-6) over time, peak levels of cytokines by response and CRS, association of cytokine levels with ICANS, and CAR+ T cell CD4/CD8 ratio by response, CRS, and ICANS. Results: As of January 2022 (median follow-up MFU 17.1 mo range 3.3–23.1), 20 pts (65% male; median age 60 y range 38–75) received cilta-cel. Pts received a median of 2 (range 1–3) prior LOT, and a median of 3.5 y (range 0.7–8.0) since MM diagnosis. 95% were refractory to last LOT, and 40% were triple-class refractory. ORR was 95%, 90% achieved CR or better, and 95% had ≥VGPR. Median times to first and best response were 1.0 mo (range 0.7–3.3) and 2.6 mo (range 0.9–13.6), respectively. 16 pts were MRD-evaluable, all of whom achieved MRD negativity at 10
-5
. Median DOR was not reached and 12-mo event-free rate was 79%. The 12-mo PFS rate was 75%. Median time to onset of CRS was 7 d (range 5–9) and occurred in 95% of pts (gr 3/4: 10%), with median duration of 3 d (range 2–12). Neurotoxicity occurred in 30% of pts (5 gr 1/2; 1 gr 3/4). 3 pts (15%) had ICANS (all gr 1/2); 1 pt had gr 2 facial paralysis. No MNTs were seen. 1 death occurred due to COVID-19 (assessed as tx-related by the investigator), 2 due to progressive disease, and 1 due to sepsis (not related to tx). Preliminary PK analyses indicate that peak expansion of CAR-T cells occurred at d 10.5 (range 8.7–42.9) and median persistence was 153.5 d (range 57.1–336.8). Conclusions: At a longer MFU of 17.1 mo, a single cilta-cel infusion led to deepening and durable responses in pts with MM who had 1–3 prior LOT and were len-refractory. Follow-up is ongoing. Updated and in-depth PK, cytokine, and CAR-T subset analyses and clinical correlation will be presented and provide novel insights into biological correlates of efficacy and safety in this pt population. This pt population is being further evaluated in the CARTITUDE-4 study (NCT04181827), which has concluded enrollment. Clinical trial information: NCT04133636.
8029
Background: In cohort B of the multicohort phase 2 CARTITUDE-2 (NCT04133636) study, the efficacy and safety of cilta-cel are being evaluated in patients (pts) with MM who had early relapse after ...initial therapy. These pts have functionally high-risk disease, with early relapse post autologous stem cell transplantation (ASCT) being a poor prognostic factor and representing an unmet medical need. We present updated results. Methods: Eligible pts had MM, received 1 prior LOT (PI and IMiD required), had disease progression per IMWG (either ≤12 mo after ASCT or ≤12 mo after start of anti-myeloma therapy for pts who did not undergo ASCT), and were tx-naive to CAR-T/anti-BCMA therapies. A single cilta-cel infusion (target dose 0.75×10
6
CAR+ viable T cells/kg) was given post lymphodepletion. Safety and efficacy were assessed, and the primary endpoint was MRD negativity at 10
-5
. Management strategies were implemented to minimize risk of movement/neurocognitive AEs (MNTs). Pharmacokinetic (PK) analyses (C
max
and T
max
of CAR+ T-cell transgene levels in blood) are being conducted, as well as analyses of levels of CRS-related cytokines (eg, IL-6) over time, peak levels of cytokines by response and CRS, association of cytokine levels with ICANS, and CAR+ T cell CD4/CD8 ratio by response, CRS, and ICANS. Results: As of January 2022, 19 pts (median age 58.0 y range 44–67; 74% male; median follow-up 13.4 mo range 5.2–21.7) received cilta-cel. 79% of pts received prior ASCT. ORR was 100.0%, 90% achieved CR or better, and 95% achieved ≥VGPR. Median time to first response and best response were 0.95 mo (range 0.9–9.7) and 5.1 mo (range 0.9–11.8), respectively. Of pts who were MRD-evaluable (n = 15), 14 (93%) achieved MRD 10
-5
negativity during this study. Median DOR was not reached and 12-mo event-free rate was 88.9%. The 12-mo PFS rate was 90%. Median time to onset of CRS was 8 d (range 5–11) and occurred in 16 (84.2%) pts (1 gr 4). CRS resolved in all pts. ICANS (gr 1) occurred in 1 pt; MNT (gr 3) occurred in 1 pt, previously reported. 1 pt died post cilta-cel due to PD at d 158. Preliminary PK analyses indicate that peak expansion of CAR-T cells occurred on d 13.1 (range 8.96–209.9) and median persistence was 76.9 d (range 40.99–221.8). Conclusions: A single cilta-cel infusion led to deep and durable responses in a functionally high-risk pt population who experienced early clinical relapse/tx failure to initial therapy, with a manageable safety profile. In this pt population with ineffective or insufficient response to ASCT, cilta-cel led to responses. Responses continue to deepen, and follow-up is ongoing. Updated and in-depth PK, cytokine, and CAR-T subset analyses and clinical correlation will be presented and provide novel insights into biological correlates of efficacy and safety in this pt population. Clinical trial information: NCT04133636.
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