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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05972720
Recruitment Status : Recruiting
First Posted : August 2, 2023
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
CARGO Therapeutics

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cancer Relapsed/Refractory Large B-cell Lymphoma (LBCL) Drug: Fludarabine (Conditional therapy) Drug: Cyclophosphamide Monohydrate (Conditional therapy) Drug: CRG-022 cells (Experimental drug) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : September 13, 2025
Estimated Study Completion Date : December 13, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Drug
Single infusion of CRG-022 following conditioning chemotherapy
 Drug: Fludarabine (Conditional therapy)
Lymphodepletion chemotherapy

Drug: Cyclophosphamide Monohydrate (Conditional therapy)
Lymphodepletion chemotherapy

Drug: CRG-022 cells (Experimental drug)
Investigational agent


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Objective response rate - Investigator assessment [ Time Frame: Up to 24-months ]
    Percentage of patients with complete or partial response determined by the investigator

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05972720


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

Locations
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Sponsors and Collaborators
CARGO Therapeutics
More Information
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Responsible Party: CARGO Therapeutics
ClinicalTrials.gov Identifier: NCT05972720    
Other Study ID Numbers: CRG-022-101
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CARGO Therapeutics:
Lymphoma
CD-22 Expressing Tumor
Chimeric Antigen Receptor
Adoptive Immunotherapy
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Primary Mediastinal B-cell
Lymphoma, Transformed
 Lymphoma, Transformed Non-Hodgkin
Lymphoma, Non-Hodgkin
CAR T
CAR T-cell therapy
Cell Therapy
Cellular Immuno-therapy
CRG-022
CD22
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
 Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists