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NCT03960840

Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

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Record History

All 47 versions: 44 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 5 entries Show 6 more changesShow less
    • Study completion moved earlier from May 31, 2028 to Jul 24, 2027
    • Enrollment target: 217 to 218
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 17 of 29 entries
    • Site details revised at 2 of 37 sites
    • Study description expanded, about 5 words
  2. Study completion pushed from Jun 30, 2027 to May 31, 2028
    • Study sites: 38 to 37
    v46
  3. Study completion moved earlier from May 31, 2028 to Jun 30, 2027
    • Study sites: 39 to 38
    v44
  4. Enrollment target: 216 to 217
    • Site details revised at 12 of 39 sites
    v43
  5. Enrollment target: 215 to 216v42
Show 38 earlier versionsHide 38 earlier versions
  1. Enrollment target: 211 to 215
    • Site details revised at 9 of 39 sites
    v41
  2. Enrollment target: 207 to 211
    • Study sites: 43 to 39
    v39
  3. Enrollment target: 206 to 207
    • Site details revised at 10 of 43 sites
    v38
  4. Site details revised at 4 of 43 sitesv37
  5. Site details revised at 1 of 43 sitesv36
  6. Enrollment target: 199 to 206v35
  7. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 225 to confirmed 199
    • Study sites: 44 to 43
    • Study description expanded, about 4 words
    v34
  8. Site details revised at 10 of 44 sitesv33
  9. Site details revised at 5 of 44 sitesv32
  10. Site details revised at 11 of 44 sitesv31
  11. Study sites: 43 to 44v30
  12. Study sites revised (43)
    • Eligibility criteria expanded, about 3 words
    v29
  13. Study sites: 41 to 43v28 Show 4 more changesShow less
    • Study completion date: Jun 30, 2027 to May 31, 2028
    • Eligibility criteria expanded, about 22 words
    • Study description revised
    • Study title expanded, about 1 word
  14. Study sites: 40 to 41v27
  15. Study sites: 36 to 40v26
  16. Study sites: 34 to 36v25
  17. Study sites: 33 to 34v24
  18. Study sites: 31 to 33v23
  19. Study sites: 30 to 31v22
  20. Start date: Jun 27, 2019 to Jun 26, 2019
    • Site contacts updated at 4 of 30 sites
    v21
  21. Phase: Phase 1 to Phase 1/2v20 Show 8 more changesShow less
    • Primary endpoints: 4 to 5
    • Interventions: YTB323 and ibrutinib (Drug), YTB323 single agent (Drug) to Ibrutinib (Drug), Rapcabtagene autoleucel single agent (Biological)
    • Eligibility criteria expanded, about 170 words
    • Secondary endpoints: 15 to 29
    • Study description expanded, about 442 words
    • Study sites revised (30)
    • Study title expanded, about 7 words
    • Study arms: 3 to 4
  22. Enrollment target: 110 to 225
    • Primary and study completion dates: Oct 9, 2025 to Jun 30, 2027
    • Study sites: 28 to 30
    v19
  23. Study sites: 21 to 28
    • Study title expanded, about 1 word
    v18
  24. Study sites: 20 to 21v17
  25. Study sites: 19 to 20v16
  26. Study sites: 17 to 19v15
  27. Study sites: 16 to 17v14
  28. Study sites: 15 to 16
    • Primary and study completion dates: Oct 8, 2025 to Oct 9, 2025
    v13
  29. Study sites: 13 to 15v12
  30. Primary and study completion dates: Mar 27, 2024 to Oct 8, 2025
    • Study sites: 11 to 13
    v11
  31. Study sites: 10 to 11
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 13 to 15
    v10
  32. Study sites: 8 to 10v9
  33. Study sites: 5 to 8v8
  34. Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 5 to 13
    • Study arms: 2 to 3
    v6
  35. Enrollment target: 50 to 110
    • Primary and study completion dates: Jan 25, 2023 to Mar 27, 2024
    • Study sites revised (5)
    v5
  36. Study sites: 3 to 5
    • Primary and study completion dates: Dec 7, 2022 to Jan 25, 2023
    v4
  37. Study sites: 1 to 3v3
  38. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Dec 9, 2022 to Dec 7, 2022
    • Start date changed from estimate of Jun 28, 2019 to Jun 27, 2019
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 1: Dose recommendation: Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only)
Timeframe: 28 days
Phase 1: Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs
Timeframe: 24 months
Phase 1: Tolerability: Ibrutinib dose modifications in the CLL/SLL arm
Timeframe: 24 months
Phase 1: Manufacture success: Number of patients infused with planned target dose
Timeframe: 24 months
Phase 2: Complete Response Rate (CRR) as assessed by local Investigator
Timeframe: 24 months

Secondary (28)

Phase 1: Complete Response (CR)/Partial Response (CR) in CLL/SLL
Phase 1: BOR of CR/PR per Lugano criteria in 3L+ DLBCL
Phase 1: Duration of response (DOR) in CLL/SLL and 3L+ DLBCL
Phase 1: BOR in ALL as assessed by an Independent Review Committee (IRC)
Phase 1: DOR in ALL as assessed by an Independent Review Committee
Show 23 moreShow less
Phase 1: EFS in ALL as assessed by an Independent Review Committee
Phase 1: BOR in ALL as assessed by local Investigator
Phase 1: DOR in ALL as assessed by local Investigator
Phase 1: EFS in ALL as assessed by local Investigator
Phase 1: Overall survival in adult ALL
Phase 1: MRD negative status by flow cytometry in adult ALL
Phase 1: Quality of life in adult ALL patients enrolled in the expansion part by use of Electronic Patient Reported Outcomes (ePRO) as per EORTC QLQ-C30 questionnaire
Phase 1: Quality of life in adult ALL patients enrolled in the expansion part by use of Electronic Patient Reported Outcomes (ePRO) as per EQ-5D-3 questionnaire
Phase 1/2: Cellular kinetics
Phase 1/2: Immunogenicity
Phase 2: Overall response rate (ORR)
Phase 2: Complete Response Rate (CRR)
Phase 2: Duration of response (DOR)
Phase 2: Progression-free survival (PFS)
Phase 2: Event-free survival (EFS)
Phase 2: Overall survival (OS)
Phase 2: Complete Response Rate (CRR) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
Phase 2: Overall response rate (ORR) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
Phase 2: Duration of response (DOR) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
Phase 2: Progression-free survival (PFS) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
Phase 2: Event-free survival (EFS) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
Phase 2: Overall survival (OS) in subgroups 1) IPI 4-5 or DH/TH and 2) IPI 3 and not DH/TH
Phase 2: Manufacturing vein to door time

Arms and interventions

CLL/SLLExperimental

Dose escalation of rapcabtagene autoleucel in combination with ibrutinib

3L+ DLBCLExperimental

Dose escalation and expansion of rapcabtagene autoleucel single agent in 3L+ DLBCL

Adult ALLExperimental

Dose escalation of rapcabtagene autoleucel single agent in adult ALL

1L HR LBCLExperimental

Rapcabtagene autoleucel single agent in 1L HR LBCL

Biologicals: Rapcabtagene autoleucel single agent

Drugs: Ibrutinib

Sites

37 sites in 8 countries

United States 12, Spain 10, France 4, Italy 3, Japan 3, Australia 2, Germany 2, Austria 1