Anti-PD1 2C12 in patients with relapsed or refractory Hodgkin lymphoma

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Expanded clinical use of the monoclonal antibody Anti-PD1 2C12 in patients with relapsed or refractory Hodgkin Lymphoma

Acronym of Scientific Title:

EXPAND-HOD STUDIO 2C12

Secondary indentifying numbers:

C31 PCL-0013

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center for Molecular Immunology (CIM), Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Calixto

Last name:

Hernandez Cruz

Medical Specialty :

Second Degree Specialist in Hematology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro 701 esquina Belascoain, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-53354392

Email address:

calixtohernandez2014@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Villa Clara, Celestino Hernández Robau University Hospital, Ana Victoria de la Torre Santos MD, Second-degree Specialist in Oncology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

25/05/2026

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Relapsed or refractory Hodgkin lymphoma

Health condition(s) code:

Hodgkin Disease

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Hemic and Lymphatic Diseases

Immunoproliferative Disorders

Immune System Diseases

Intervention(s):

Group Anti-PD1 2C12 (Experimental): Anti-PD1 2C12 monoclonal antibody; 200 mg every three weeks (intravenous infusion), until disease progression or unacceptable toxicity occurs

Intervention code:

Antibodies, Monoclonal

Administration, Intravenous

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Adverse events with grade 3-5 and a proven causal relationship to the treatment with the monoclonal antibody Anti-PD1 2C12 (The proportion of patients who develop grade 3-5 adverse events (clinical and laboratory) with a proven causal relationship (definite, very probable or probable)). Measurement time: Up to 30 days after the last dose of treatment (maximum 24 months).

Key secondary outcomes:

1. Adverse Events-AE (-Occurrence of the EA in the subject (Yes, No); Description of the EA (name of the EA presented); Organ and system (based on anatomical or physiological system, etiology or purpose); -Duration of the EA (difference between the start and end dates of the EA, and hours in case of a duration of less than 24 hours); Intensity of the adverse event (Mild, Moderate, Severe, life-threatening or disabling adverse event, and fatal adverse event); Severity of the AE (Serious, Not serious); Attitude towards the treatment under study (no changes in dose, temporary or permanent interruption of the treatment under study); Result of the EA (recovered/resolved, improving/in resolution, persistent/unresolved, with sequelae requiring treatment); Causal relationship (1. Definite, 2. Very Probable, 3. Probable, 4. Possible, 5. Not related, 6. Unknown)). Measurement time: up to 30 days after the last dose of treatment received and up to a maximum of 24 months. 2. Antibodies against the monoclonal antibody Anti-PD1 2C12 (Positive, Negative). Measurement time: At baseline and, every 12 weeks while the treatment is maintained. 3. Neutralizing antibodies against the Anti-PD1 2C12 monoclonal antibody (Positive, Negative). Measurement time: At baseline and, every 12 weeks while the treatment is maintained. 4. Objective response rate (Proportion of patients who achieve complete response-CR or partial response-PR according to Cheson-Lugano criteria). Measurement time: At baseline, at weeks 12; 24; 48; 72 and at 24 months or patient death 5. Progression-free survival-PFS (Time from the start of treatment until objective disease progression or death of the patient from any cause). Measurement time: 24 months. 6. Overall survival-OS (Time from the start of treatment until the patient's death from any cause, or until the date of last news). Measurement time: 24 months. 7. Duration of response (Time from the first documentation of CR or PR to the first evidence of relapse, progression, or death from any cause). Measurement time: 24 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Confirmed histological diagnosis of classical Hodgkin lymphoma. 2. Relapsed or refractory disease after at least two previous lines of standard treatment (including chemotherapy and, where possible, autologous hematopoietic stem cell transplantation). 3. Age ≥ 18 years at the time of inclusion. 4. Previous cancer-specific treatment more than six weeks before inclusion. 5. Functional status with an ECOG score ≤ 2, according to the Eastern Cooperative Oncology Group scale. 6. Adequate organic function, defined as: a) Hemoglobin ≥ 8 g/dL b) Neutrophils ≥ 1.0 × 10⁹/L c) Platelets ≥ 75 × 10⁹/L. d) Creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min. e) Total bilirubin ≤ 1.5 times ULN f) AST and ALT ≤ 3 times ULN (or ≤ 5 times ULN if there is liver involvement due to disease). *ALT = alanine aminotransferase, AST = aspartate aminotransferase g) TSH within normal limits. If TSH is not within normal limits at baseline, the participant may be eligible if free T3 and T4 are within normal limits. TSH < 10 miU/L will be accepted in patients with known controlled hypothyroidism. 7. Commitment to use contraceptive methods, from the signing of the informed consent until six months after the administration of the last dose of the Anti-PD1 2C12 monoclonal antibody, in men or women of childbearing age. 8. Life expectancy of at least three months. 9. Voluntary participation in the research through the signing of an informed consent form.

Exclusion criteria:

1. History of hypersensitivity or allergy to any of the components of the investigational product. 2. Prior treatment with another anti-PD-1 or anti-PD-L1 antibody in the last three months. 3. Currently receiving other investigational medications. 4. Active autoimmune disease requiring systemic immunosuppression at the time of inclusion or that has required systemic treatment within the past two years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Patients with the following conditions are excluded from this criterion: - Type 1 diabetes mellitus (insulin replacement therapy) -Hipotiroidismo controlado (tratamiento de reemplazo con tiroxina) -Vitiligo or psoriasis that do not require systemic treatment - Physiological replacement therapies with corticosteroids for adrenal or pituitary insufficiency, which are not considered systemic immunosuppression 5. Current use of systemic immunosuppressants or in the 14 days prior to the start of treatment (except corticosteroids at doses ≤ 10 mg/day of prednisone or equivalent). 6. Severe active infection or any other active infection requiring intravenous systemic therapy at the time of inclusion, including, but not limited to: tuberculosis, uncontrolled hepatitis B or C, untreated HIV. 7. Pregnant women, women who are breastfeeding or of childbearing age who are unwilling to use contraceptive methods throughout the study. 8. Positive pregnancy test at the time of selection (only applies to women of childbearing age). 9. History of allogeneic hematopoietic stem cell transplantation with active graft-versus-host disease. 10. Presence of another active malignant neoplasm other than Hodgkin lymphoma, except basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix. 11. Uncontrolled serious medical conditions (e.g., heart failure, advanced lung disease) that may interfere with safe participation in the study. 12. Decompensated comorbidities or acute complications of the primary disease that compromise life, such as massive pleural effusion or pericardial effusion, during the informed consent process or evaluation for inclusion. 13. Interstitial lung disease or a history of pneumonitis requiring oral or intravenous steroids at the evaluation stage for inclusion. 14. Pulmonary lymphangitis, bleeding or perforation of an organ. 15. Concomitant diseases that increase the risk of immune-related adverse events. 16. Metastasis to the central nervous system or carcinomatous meningitis. 17. History of psychiatric or cognitive disorders, or substance addiction that prevents cooperation with the requirements of the study. 18. Inability to comply with scheduled visits and evaluations.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

15

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Calixto

Last Name:

Hernandez Cruz

Specialty:

Second Degree Specialist in Hematology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 esquina Belascoain, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

Email :

calixtohernandez2014@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Lidia

Last Name:

Morejon Gamboa

Specialty:

First-degree specialist in Immunology

Affiliation:

Center for Molecular Immunology (CIM)

Postal Address:

216th Street, Corner of 15th Street, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72717933

Email :

lidiam@cim.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijeiras Clinical Surgical Hospital

Celestino Hernández Robau University Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

07/05/2026

Postal address of Ethic Committee :

San Lazaro 701esquina Belascoain, Centro Habana, Havana, ZC:10400, Cuba

Calle Cuba #564 entre Barcelona y Hospital, Santa Clara, Villa Clara C.P: 50100, Cuba

Telephone:

+53-52833178

+53-56096863

Email:

jorgeluishernandezcastro52@gmail.com

jossylugo347@gmail.com

About study completion

Section to complete the data related to the study completion.

Study completion date:

29/12/2028

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000478

Date of Registration in Primary Registry:

18/05/2026

Record Verification Date:

2026/05/18

Next update date:

2027/05/18

Link to the spanish version:

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Anti-PD1 2C12 in patients with relapsed or refractory Hodgkin lymphoma

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