Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse

NCT06271057 | Recruiting Phase 2 DMC

• 1 other identifier: CARMOD
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 13

Brief Summary

This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first. Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study. The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion. The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.

Conditions

Diffuse Large B-cell Lymphoma Refractory; Refractory Primary Mediastinal Large B-Cell Lymphoma; Refractory Transformed B-cell Non-Hodgkin Lymphoma; Refractory High Grade B-Cell Lymphoma

Keywords

eligible for CAR T-cells therapy

Outcome Measures

Primary Outcomes (1)

• Complete metabolic response rate (CMR rate)

  efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion

  3 months

Secondary Outcomes (9)

• Objective response rate (ORR)

  at 1 month, 3 months, 6 months, 1 year and 2 years, from CAR-T infusion

• Objective response rate (ORR)

  at 1 month and 3 months

• Complete response rate (CRR)

  at 1 Month, 6 Months, 1 year, and 2 years

• Duration of response (DR)

  2 years

• Event-free survival (EFS)

  2 years

Study Arms (1)

golcadomide post CAR T-cells

EXPERIMENTAL

0.3 mg - Per Os - every week - 6 months

Drug: golcadomide

Interventions

golcadomide DRUG

golcadomide 0.3 mg weekly from D+5 post CAR T-cells administration until D+166

Also known as: BMS-986369, CC-99282

golcadomide post CAR T-cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
• Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)
• Eligible for any commercialized market authorized anti-CD19 CAR T-cells
• Performance Status 0 or 1
• With aggressive large B-cell lymphoma, including:
• diffuse large B-cell lymphoma
• Primary mediastinal B-cell lymphoma
• Any transformed follicular or marginal zone lymphoma
• high-grade B-cell lymphoma (HGBL) Note: patients with Central Nervous System (CNS) involvement could be included but not patients with primary CNS lymphoma
• Available biopsy for centralized review
• With a CAR T-cells indication as soon as 2nd line treatment no later than in 4th line, previously validated by the multidisciplinary tumor board Note: Any treatment performed prior to leukapheresis is considered a line of treatment
• Total MetabolicTumor Volume (TMTV) \> 80 ml, measured by centralized review, on 18FDG-PET (positron emission tomography) done just before starting CAR T-cells procedure (i.e., D-13 +/- 4 days before CAR-T cells infusion)
• Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if \> 60-year-old or Cockcroft-Gault if \<60yo) \>45 mL/min,
• Adequate hepatic function:
• aspartate aminotransferase/alanine aminotransferase (ALT/AST) ≤ 3.0 x ULN. (Note: In the case of documented liver involvement by lymphoma, ALT/AST must be ≤ 5.0 x ULN)

You may not qualify if:

• History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years
• Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor
• History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines
• Significant pulmonary function impairment and oxygen saturation (SaO2) \< 92% on room air
• Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment
• History of severe immediate hypersensitivity reaction to any of the agents used in this study
• Current treatment with strong CYP3A4/5 modulators (see appendix 13)
• Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential
• Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)
• Person deprived of his/her liberty by a judicial or administrative decision
• Person hospitalized without consent
• Adult person under legal protection

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead
• Lymphoma Study Association: collaborator

Study Sites (13)

Hopital Henri Mondor

Créteil, 94010, France

RECRUITING

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Chu de Grenoble

La Tronche, 38700, France

RECRUITING

Chru de Lille

Lille, 59037, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13273, France

RECRUITING

Chu de Montpellier

Montpellier, 34090, France

RECRUITING

Chu de Nantes

Nantes, 44093, France

RECRUITING

Hopital Saint-Louis

Paris, 75475, France

RECRUITING

Chu de Bordeaux

Pessac, 33604, France

RECRUITING

Chu Pontchaillou

Rennes, 35033, France

RECRUITING

Centre Henri Becquerel

Rouen, 76038, France

RECRUITING

Iuct Oncopole

Toulouse, 31059, France

RECRUITING

Chu Brabois

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Study Officials

• Catherine THIEBLEMONT, Prof. Dr.

  Hôpital Saint-Louis

  PRINCIPAL INVESTIGATOR

• Gabriel BRISOU, Prof. Dr.

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

• François-Xavier GROS, Prof. Dr.

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie DOYEN

CONTACT

+33 4 27 01 27 36; stephanie.doyen@lysarc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: June 14, 2024
• Primary Completion: January 15, 2026
• Study Completion (Estimated): October 20, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

FR (13)