Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

Conditions

• Large B-cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cemacabtagene ansegedleucel — GENETIC
  An allogeneic CAR T cell therapy targeting CD19
• Fludarabine — DRUG
  Chemotherapy for lymphodepletion
• Cyclophosphamide — DRUG
  Chemotherapy for lymphodepletion
• Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™ — DEVICE
  A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.

Study Details

This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.

Key Dates

Start date

Jun 18, 2024

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2032

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: cemacabtagene ansegedleucel
  Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
• Other: Observation
  Participants do not receive any study treatments. They are observed as per the current standard of care.

Primary Outcome Measure

Event-free survival per independent review committee assessment [ Time Frame: Up to 60 months ]

Central Contacts

• Allogene Therapeutics, Inc
  +1 415-604-5696
  [email protected]

Locations (60)

Find similar trials in Gilbert, AZ

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