TABLE 7.
Clinical trials of CAR‐T cell therapy in aggressive B‐cell lymphomas
| Trial Name (NCT number) | Phase | Indication | Treatment | Key Endpoints | Line of Therapy |
|---|---|---|---|---|---|
| BELINDA (NCT03570892) | 3 | Adult B‐cell NHL | Tisa‐cel vs standard of care a | EFS, OS, ORR, DOR, QoL | 2nd |
| TRANSFORM (NCT03575351) | 3 | Adult r/r B‐cell NHL | Liso‐cel vs standard of care b | EFS, CRR, PFS, OS, ORR, DOR, QoL, AEs | 2nd |
| ZUMA‐7 (NCT03391466) | 3 | Adult r/r DLBCL | Axi‐cel vs standard of care c | EFS, ORR, OS, mEFS, PFS, DOR, QoL, safety | 2nd |
| TRANSCEND WORLD (NCT03484702) | 2 | Adult aggressive B‐cell NHL | Liso‐cel | ORR, AEs, CRR, EFS, PFS, OS, DOR, QoL, pharmacokinetics | ≥2nd |
| ZUMA‐12 (NCT03761056) | 2 | Adult high‐risk LBCL | Axi‐cel | CR, ORR, DOR, EFS, PFS, OS, safety | 1st |
| PORTIA (NCT03630159) | 1b | Adult r/r DLBCL | Tisa‐cel + pembrolizumab | ORR, DOR, PFS, OS, cellular kinetics | ≥3rd |
| NCT03876028 | 1b | Adult r/r DLBCL | Tisa‐cel + ibrutinib | Safety, ORR, DOR, PFS, OS, cellular kinetics | ≥3rd |
| PLATFORM (NCT03310619) | 1/2 | Adult r/r B‐cell NHL | Liso‐cel + durvalumab or CC‐122 | OS, ORR, DOR, CRR, AEs, PFS, QoL | ≥3rd |
| ZUMA‐6 (NCT02926833) | 1/2 | Adult r/r DLBCL | Axi‐cel + atezolizumab | CRR, ORR, DOR, PFS, OS, AEs | ≥3rd |
| BIANCA (NCT03610724) | 2 | Pediatric and young adult B‐cell NHL | Tisa‐cel | ORR, DOR, EFS, RFS, PFS, OS, cellular kinetics | ≥2nd |
| ELARA (NCT03568461) | 2 | Adults with r/r FL (grades 1, 2, or 3a) | Tisa‐cel | CR, ORR, OS, cellular kinetics, safety, PRO | ≥2nd |
| TRANSCEND FL (NCT04245839) | 2 | Adult r/r FL (grades 1, 2, or 3a) or MZL | Liso‐cel | CR, ORR, DOR, PFS, OS, safety, pharmacokinetics, QoL | ≥2nd |
| ZUMA‐5 (NCT03105336) | 2 | Adults with r/r FL (grades 1, 2, or 3a) or MZL | Axi‐cel | ORR, safety, DOR, PFS, OS | ≥3rd |
| TARMAC (NCT04234061) | 2 | Adults with r/r MCL | Tisa‐cel + ibrutinib | CR, OR, safety, DOR, PFS, OS | ≥2nd |
| ZUMA‐2 (NCT02601313) | 2 | Adults with r/r MCL | Brexucabtagene autoleucel | OR, DOR, BOR, PFS, OS, safety, pharmacokinetics, QoL | ≥3rd |
| NCT03331198 | 1/2 | Adults with r/r CLL or SLL | Liso‐cel ± ibrutinib | CR, safety, ORR, PFS, OS, QoL | ≥3rd d |
Abbreviations: AE, adverse event; axi‐cel, axicabtagene ciloleucel; BOR, best objective response; CAR, chimeric antigen receptor; CLL, chronic lymphocytic leukemia; CR, complete response; CRR, complete response rate; DLBCL, diffuse large B‐cell lymphoma; DOR, duration of response; EFS, event‐free survival; FL, follicular lymphoma; LBCL, large B‐cell lymphoma; liso‐cel, lisocabtagene maraleucel; MCL, mantle cell lymphoma; mEFS, modified event‐free survival; MZL, marginal zone lymphoma; NHL, non‐Hodgkin lymphoma; OR, objective response; ORR, overall response rate; OS, overall survival; PFS, progression‐free survival; PRO, patient‐reported outcomes; QoL, quality of life; r/r, relapsed or refractory; RFS, relapse‐free survival; SLL, small lymphocytic lymphoma; tisa‐cel, tisagenlecleucel.
Patients will receive investigator's choice of platinum‐based immunochemotherapy followed in responding patients by high‐dose chemotherapy and autologous hematopoietic stem cell transplant.
Salvage therapy per physician's choice before proceeding to high‐dose chemotherapy and hematopoietic stem cell transplant.
Platinum‐containing salvage chemotherapy followed by high‐dose therapy and autologous stem cell transplant in responders.
Patients in the liso‐cel cohort only.