Relapsed Advanced LymphomasPhase 1ADITI-1NCT06755450
Study Evaluating Safety Pharmacokinetics and Pharmacodynamics of AUR112 in Patients With Relapsed Advanced Lymphoma
A Phase 1 study testing AUR112 in people with Relapsed Advanced Lymphomas, run by Aurigene Discovery Technologies Limited at 19 sites in India.
Trial summary
A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Relapsed Advanced Lymphomas
- What is being tested?
- AUR112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 19 sitesIndia
- Study dates
- 15 Jan 2025to 15 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Acceptable bone marrow and organ function at screening as described below:
- ANC ≥ 1000/μL (without WBC growth factor support)
- Platelet count: For patients with CLL ≥ 50,000/μL; For patients with lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrow involvement. These thresholds should be qualified without platelet transfusion support.
- Hemoglobin ≥ 9 g/dL (RBC Transfusion is allowed to achieve this Hb)
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- Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)
- AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
- ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
- Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance [eCrCl]: eCrCl = [140- Age] × Weight [kg] × [0.85 if Female] / [72 × serum creatinine (mg/dL)]).
- Ability to swallow and retain oral medications
- Histopathological diagnosis of Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) or Hodgkin disease. Note:
- 5a. The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson et al. 2014) at screening. 5b. The lymphomas included in this study must fall within one of the following 2017 World Health Organization categories except lymphoma mentioned in Exclusion criterion #5:
- Mature B-cell neoplasms (excluding plasma cell neoplasms, heavy chain disease, and primary central nervous system [CNS] lymphoma).
- Mature T- and NK-cell neoplasms.
- Hodgkin lymphomas 5c. The CLL should be Binet Stage C/Rai stage III or IV, as per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (Hallek et al. 2018).
- 6. In the case of subjects who have lymphoma for which high-dose chemotherapy and autologous stem cell transplantation (HDASCT) is considered a standard curative therapy, eligibility for this study requires that the subject's disease has relapsed after HDASCT, or the subject is not eligible for HD-ASCT, or that the subject has refused HD-ASCT.
- 7. In the case of patients who have lymphoid malignancies for which CAR-T therapy is indicated, eligibility for this study requires that the disease has relapsed after CAR-T, or the patient is not eligible for CAR-T, or the patient has refused CAR-T, or the CAR-T is not available locally.
- 8. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson et al. 2014) or evidence of measurable disease as per iwCLL Criteria for CLL (Hallek et al. 2018). Note: Patients with Small Lymphocytic Lymphoma (SLL) alone or in combination with CLL are allowed.
- 9. Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally. The patients must have relapsed or refractory to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin disease.
- Note:
- Any cancer patient with access to any effective therapy locally must not be enrolled.
- Patients with CLL should have documented evidence for progressive or symptomatic disease (active disease) and must have indications for treatment (Hallek et al 2018).
- Patients with indolent lymphomas also must have indications for treatment, such as the GELF (Brice et al 1997) or BNLI criterion (Ardeshna et al 2003)
Who cannot join
- Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study. Note: Concomitant use of low dose prednisone (up to 10 mg/day) is allowed
- Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0. 1
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
- Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1
- Patients with Burkitt's lymphoma, Burkitt-like lymphoma, posttransplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides (MF), or Sezary syndrome (SS).
- Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated (> 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed.
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- Patients with lymphoma that requires immediate cytoreductive therapy.
- Patients with low-grade lymphoma or indolent lymphoma that does not meet conventional criteria (Jeong SH, 2022) for requiring treatment.
- Patients on drugs which are inhibitors of P-gp or BCRP or UGT1A1 and when these drugs cannot be discontinued from at least one week prior to Cycle 1 Day 1. Note: These drugs will be prohibited during Cycle 1 of therapy.
- Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)
- Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.
- Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
- Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve).
- The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study
- . Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.
- Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.
- QTcF (Fridericia) interval >470 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness (e.g. renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness/social situations or clinically significant laboratory / ECG abnormalities at screening, any or a combination of illnesses, which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
- Current swab-positive or suspected (under investigation) Covid19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Cycle 1 Day 1.
- History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study.
- Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit.
- Lactating women or WOCBP or a man with a partner who has childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods(hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap) during the screening period, while on AUR112 and at least 28 days after last dose
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
India19 sites, 13 recruiting
- Active, not recruiting
Health Care Global Enterprises
Bangalore, Karnataka, 560027
- Recruiting
Srinivasam Cancer Care Multi Speciality Hospitals India Pvt Ltd. , Bangalore 560072.
Bangalore, Karnataka, 560027
Dr. K.C. Lakshmaiah, MBBS, MD, DM, +91 9448055949, kcluck@gmail.com
- Recruiting
AIIMS, Bhubaneswar
Bhubaneswar, Odisha, 751019
Dr. Sourav Kumar Mishra, MBBS, MD,DM, 7008651823, drskmishra1984@gmail.com
- Recruiting
Jeevan Amrut Hematology Center, Aurangabad
Chhatrapati Sambhajinagar, Maharashtra, 431001
Dr Manoj Toshniwal, MBBS, MD,DM, +91- 922530842, drmanoj.jeeevanamrut@gmail.com
- Active, not recruiting
Somani Hospital
Jaipur, Rajasthan, 302019
- Recruiting
National Cancer Institute , All India Institute of Medical Sciences
Jhajjar, Haryana, 124105
Dr. Akash Kumar, MBBS, MD, DM, 9910850134, akashjha08@yahoo.com
- Active, not recruiting
Tata Medical Centre
Kolkata, West Bengal, 700160
- Recruiting
HCG Cancer Centre
Nagpur, Maharashtra, 440026
Dr.Nishad Dhakate, MBBS,MD,DM (Haemato-oncology), 7042832629, dr.nishad.dhakate@gmail.com
- Active, not recruiting
AIIMS, New Delhi
New Delhi, New Delhi, 110029
- Recruiting
Tata Memorial Hospital
Parel, Mumbai, 400012
Dr. Hasmukh Jain, MD, DM Medical Oncology, 77189 82948, researchahl81@gmail.com
- Recruiting
Sahyadri Hospital Private Limited
Pune, Maharashtra, 410014
Dr. Shashikant Janardan Apte, MBBS,MD,FRCPA, 9822404983, shashikant.apte@gmail.com
- Recruiting
Novo Solitaire Care
Pune, Maharashtra, 411014
Dr. Aniket Balasaheb Mohite, MBBS, MD, DM, +91-9960593303, novosolitairecare@gmail.com
- Not yet recruiting
Armed Forces Medical College
Pune, Maharashtra, 411040
Dr.Uday Yanamandra, MBBS, MD, DM,DNB, 8195035551, udayj2@gmail.com
- Recruiting
AIIMS, Rishikesh
Rishikesh, Uttarakhand, 249203
Dr.Uttam Kumar Nath, MBBS, MD, DM, 9433982756, Uttam.haemat@aiimsrishikesh.edu.in
- Active, not recruiting
Max Super Specialty Hospital
Sāket, New Delhi, 110017
- Recruiting
Onco Life Cancer, Centre, Satara
Satara, Maharashtra, 415519
Dr. Vinod R Patil, MBBS, DM (Clinical haematology, +91- 9819865983, drvinodpatilolcccr@gmail.com
- Recruiting
Sunact Cancer Institute Pvt. Ltd
Thane, Maharashtra, 400 615
Dr. Vijay Maruti Patil, MBBS, MD, DM, 9136129135, vijaypgi@gmail.com
- Active, not recruiting
Sir Sayajirao General Hospital (SSG)
Vadodara, Gujarat, 390001
- Recruiting
Siddharth Gupta Memorial Hospital,
Wardha, Maharashtra, 442107
Dr Modak Pradnya Dharmapal, MBBS,DNB, 7410770773, pradnyamodak0005@gmail.com
About this study
Official title: A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 In Patients With Relapsed Advanced Lymphoma (ADITI-1)
A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)
Read the detailed description
The main objective of Part 1 will be to evaluate the safety and tolerability of the study drug AUR112.
Dose escalation of single agent AUR112 will be conducted in the classic 3+3 design. Safety including Dose Limiting Toxicities (DLTs), PK, and PD will be assessed at each dose. Dose escalation will continue until safety limits are reached or the escalation will stop earlier if PK/PD data suggest that a biologically active dose has reached.
The objective is to determine dose(s) which will be investigated in future trials.
- Conditions
- Relapsed Advanced Lymphomas
- Being tested
- AUR112
- Keywords
- Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma, Relapse Advanced Lymphomas
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR112Drug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| AUR112 | Experimental | Experimental: AUR112, 100mg to 1200mg Currently, six (6) planned dose levels are 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, and 1200 mg once daily (QD).
AUR112: Once daily Receives: Drug: AUR112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
First cycle Dose Limiting Toxicities (DLT).
Number of participants with dose limiting toxicities (DLT) taking AUR112
Measured: 28 days (Cycle 1)
Safety of AUR112 as measured by the number of participants with treatment related adverse events (AE) graded according to NCI CTCAE version 5.0
The assessment of safety was based on the frequency of deaths, adverse event (AE), serious adverse event (SAE)s leading to discontinuation of study drug, and abnormalities in specific laboratory assessments. AEs and laboratory values will be graded for severity according to NCI CTCAE version 5.0
Measured: 28 days
To determine the doses to be recommended for evaluation in future studies.
Determine selected dose(s) to be studied in future clinical trials
Measured: 28 days
Pharmacokinetics: Maximum concentration (Cmax)
Maximum concentration of AUR112
Measured: [Time Frame: Day 1 and Day 15]
Pharmacokinetics: Time to Maximum concentration (Tmax)
Tmax in hours
Measured: [Time Frame: Day 1 and Day 15]
Pharmacokinetics: Area under the curve (AUC)
Area under the curve (AUC) of AUR 112 in h* mcg/mL
Measured: [Time Frame: Day 1 and Day 15]
Pharmacokinetics: Mean Residence Time (MRT)
Average time the drugs stays in the body
Measured: [Time Frame: Day 1 and Day 15]
Pharmacokinetics: Terminal elimination half-life
Terminal elimination half-life of AUR 112 in hours
Measured: [Time Frame: Day 1 and Day 15]
Maximum concentration (Cmax) administered under fasting/fed condition
Compare in fast and fed conditions
Measured: [Time Frame: Day 8 and Day 9]
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Compare Tmax in fast and fed conditions
Measured: [Time Frame: Day 8 and Day 9]
Area under curve (AUC) administered under fasting/fed condition
Compare AUC in fast and fed conditions
Measured: [Time Frame: Day 8 and Day 9]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Advanced LymphomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Sequential Assignment Dose Escalation Design
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurigene Discovery Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akhil Kumar, Principal investigator, Aurigene Oncology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755450
- Sponsor's protocol ID
- AUR112-101
- Acronym
- ADITI-1
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 In Patients With Relapsed Advanced Lymphoma (ADITI-1)
- ClinicalTrials.gov ID
- NCT06755450
- Acronym / sponsor ID
- ADITI-1 / AUR112-101
- Conditions
- Relapsed Advanced Lymphomas
- Keywords
- Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma, Relapse Advanced Lymphomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aurigene Discovery Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)
Detailed description
The main objective of Part 1 will be to evaluate the safety and tolerability of the study drug AUR112.
Dose escalation of single agent AUR112 will be conducted in the classic 3+3 design. Safety including Dose Limiting Toxicities (DLTs), PK, and PD will be assessed at each dose. Dose escalation will continue until safety limits are reached or the escalation will stop earlier if PK/PD data suggest that a biologically active dose has reached.
The objective is to determine dose(s) which will be investigated in future trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment Dose Escalation Design
| Arm | Type | Receives |
|---|---|---|
| AUR112 | Experimental | Drug: AUR112Experimental: AUR112, 100mg to 1200mg Currently, six (6) planned dose levels are 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, and 1200 mg once daily (QD). AUR112: Once daily |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Males and females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Acceptable bone marrow and organ function at screening as described below:
- Ability to swallow and retain oral medications
- Histopathological diagnosis of Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) or Hodgkin disease. Note:
Key exclusion criteria (22 listed)
- Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study. Note: Concomitant use of low dose prednisone (up to 10 mg/day) is allowed
- Presence of an acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0. 1
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
- Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1
- Patients with Burkitt's lymphoma, Burkitt-like lymphoma, posttransplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides (MF), or Sezary syndrome (SS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUR112Once daily | Drug | AUR112 |
Primary outcome
First cycle Dose Limiting Toxicities (DLT).
Time frame: 28 days (Cycle 1)
Number of participants with dose limiting toxicities (DLT) taking AUR112
Safety of AUR112 as measured by the number of participants with treatment related adverse events (AE) graded according to NCI CTCAE version 5.0
Time frame: 28 days
The assessment of safety was based on the frequency of deaths, adverse event (AE), serious adverse event (SAE)s leading to discontinuation of study drug, and abnormalities in specific laboratory assessments. AEs and laboratory values will be graded for severity according to NCI CTCAE version 5.0
To determine the doses to be recommended for evaluation in future studies.
Time frame: 28 days
Determine selected dose(s) to be studied in future clinical trials
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: [Time Frame: Day 1 and Day 15]
Maximum concentration of AUR112
Pharmacokinetics: Time to Maximum concentration (Tmax)
Time frame: [Time Frame: Day 1 and Day 15]
Tmax in hours
Pharmacokinetics: Area under the curve (AUC)
Time frame: [Time Frame: Day 1 and Day 15]
Area under the curve (AUC) of AUR 112 in h* mcg/mL
Pharmacokinetics: Mean Residence Time (MRT)
Time frame: [Time Frame: Day 1 and Day 15]
Average time the drugs stays in the body
Pharmacokinetics: Terminal elimination half-life
Time frame: [Time Frame: Day 1 and Day 15]
Terminal elimination half-life of AUR 112 in hours
Maximum concentration (Cmax) administered under fasting/fed condition
Time frame: [Time Frame: Day 8 and Day 9]
Compare in fast and fed conditions
Time to Maximum concentration (Tmax) administered under fasting/fed condition
Time frame: [Time Frame: Day 8 and Day 9]
Compare Tmax in fast and fed conditions
Area under curve (AUC) administered under fasting/fed condition
Time frame: [Time Frame: Day 8 and Day 9]
Compare AUC in fast and fed conditions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akhil Kumar principal investigator
Aurigene Oncology Limited
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AUR112 in people with Relapsed Advanced Lymphomas, run by Aurigene Discovery Technologies Limited at 19 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suchit D Kumbhare (+91- 8104730078, suchit_k@aurigene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First cycle Dose Limiting Toxicities (DLT). (time frame: 28 days (Cycle 1)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.