A Phase 2 Study of CRG-022 in Patients With Relapsed/Refractory Large B-cell Lymphoma

• ClinicalTrials.gov Identifier: NCT05972720
• Recruitment Status: Recruiting
• First Posted: August 2, 2023
• Last Update Posted: May 7, 2024
• Sponsor: CARGO Therapeutics
• Information provided by (Responsible Party): CARGO Therapeutics

Tracking Information

• First Submitted Date: July 25, 2023
• First Posted Date: August 2, 2023
• Last Update Posted Date: May 7, 2024
• Actual Study Start Date: August 1, 2023
• Estimated Primary Completion Date: September 13, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2023)

Objective response rate - Blinded independent review [ Time Frame: Up to 24 months ]

Percentage of patients with complete or partial response determined by a blinded independent review committee

Original Primary Outcome Measures (submitted: July 25, 2023)

Objective response rate - Blinded independent review [ Time Frame: 3 months, 9 months, and 24 month post-treatment follow-up after CRG-022 infusion ]

Percentage of participants with complete or partial response determined by a blinded independent review committee according to 2014 Lugano criteria.

Current Secondary Outcome Measures (submitted: November 7, 2023)

• Objective response rate - Investigator assessment [ Time Frame: Up to 24-months ]
  Percentage of patients with complete or partial response determined by the investigator
• Complete response rate [ Time Frame: Up to 24-months ]
  Percentage of patients who achieve a Complete Response determined by independent review committee and investigators assessment
• Duration of response [ Time Frame: Up to 24-months ]
  Duration of response (the time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause) determined by independent review committee and investigators
• Duration of complete response [ Time Frame: Up to 24-months ]
  Time from the date of the first occurrence of CR to the date of progression, relapse, or death from any cause determined by independent review committee and investigators.
• Progression-free survival [ Time Frame: Up to 24-months ]
  Progression-free survival (the time from CRG-022 infusion until the first occurrence of disease progression or relapse) determined by independent review committee and investigator assessment
• Overall Survival [ Time Frame: Up to 24-months ]
  Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the Investigator.
• Incidence rate of adverse events [ Time Frame: From Screening up to 15 years at protocol-defined timepoints ]
  Percentage of patients with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.

Original Secondary Outcome Measures (submitted: July 25, 2023)

• Objective response rate - Investigator assessment [ Time Frame: 3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion ]
  Percentage of participants with complete or partial response determined by the investigator according to Lugano criteria
• Complete response rate [ Time Frame: 3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion ]
  Percentage of participants who achieve a Complete Response determined by independent review committee and investigators assessment according to Lugano criteria
• Duration of response [ Time Frame: 3 months, 9 months and 24-month post-treatment follow-up after CRG-022 infusion ]
  Duration of response (the time from the date of the first occurrence of response to the date of progression, relapse, or death from any cause) determined by independent review committee and investigators according to Lugano criteria.
• Progression-free survival [ Time Frame: 3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion ]
  Progression-free survival (the time from CRG-022 infusion until the first occurrence of disease progression or relapse) determined by independent review committee and investigator assessment according to Lugano criteria.
• Overall Survival [ Time Frame: 3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion ]
  Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the investigators.
• Incidence rate of adverse events [ Time Frame: From Screening up to 15 years at protocol-defined timepoints ]
  Percentage of participants with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 2 Study of CRG-022 in Patients With Relapsed/Refractory Large B-cell Lymphoma
• Official Title: An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of CRG-022, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy
• Brief Summary: This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of CRG-022, a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).
• Detailed Description: CRG-022 is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of CRG-022 in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of CRG-022.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cancer
• Relapsed/Refractory Large B-cell Lymphoma (LBCL)

Intervention

• Drug: Fludarabine (Conditional therapy)
  Lymphodepletion chemotherapy
• Drug: Cyclophosphamide Monohydrate (Conditional therapy)
  Lymphodepletion chemotherapy
• Drug: CRG-022 cells (Experimental drug)
  Investigational agent

Study Arms

Experimental: Experimental Drug

Single infusion of CRG-022 following conditioning chemotherapy

Interventions:

• Drug: Fludarabine (Conditional therapy)
• Drug: Cyclophosphamide Monohydrate (Conditional therapy)
• Drug: CRG-022 cells (Experimental drug)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 25, 2023): 123
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 13, 2026
• Estimated Primary Completion Date: September 13, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Aged ≥18 years
• Relapsed or refractory large B-cell lymphoma.
• For enrollment in cohort 1, patients must have previously received a CD19-directed CAR T-cell therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematological, renal, and liver function

Key Exclusion Criteria:

• Clinically significant concurrent medical illness
• Active infection requiring systemic antibiotics
• Prior allogeneic stem cell transplant or allogeneic cell therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: CargoTx Email address; (650) 499-8952; clinicaltrials@cargo-tx.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05972720
• Other Study ID Numbers: CRG-022-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CARGO Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: CARGO Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: CARGO Therapeutics
• Verification Date: May 2024