Phase 1 Lymphoma Trial, Recruiting NCT06755450 Sponsor: Aurigene Discovery Technologies Limited Condition: Lymphoma
Back to Lymphoma

Phase 1 Lymphoma Trial, Recruiting

NCT06755450
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older (any gender)
  • People whose general health and ability to carry out daily activities meets a specific standard (a score of 0 or 1 on a medical performance scale, meaning fully active or restricted only in strenuous activity — confirm with trial site)
  • People whose blood counts, liver function, and kidney function fall within acceptable ranges at the screening stage (the trial site will measure and assess these)
  • People who are able to swallow and keep down tablets or capsules
  • People who have been diagnosed with Non-Hodgkin Lymphoma (a cancer of the lymph system), Chronic Lymphocytic Leukaemia (a type of blood cancer, also called CLL), or Hodgkin disease (another cancer of the lymph system)
  • People whose lymphoma is at an advanced stage (Stage III or IV), or whose CLL is at an advanced stage (Binet Stage C or Rai Stage III/IV), as determined by recognised medical guidelines
  • People whose lymphoma has come back or stopped responding to at least 2 previous rounds of treatment, and for whom no effective standard curative treatment remains available locally
  • People whose disease, if a stem cell transplant is normally considered a standard curative option, has either come back after that transplant, or who are not suitable for a transplant, or who have declined a transplant
  • People whose disease, if a specialised immune cell therapy (CAR-T) is normally recommended, has either come back after that therapy, or who are not suitable for it, or who have declined it, or for whom it is not available locally
  • People whose disease can be measured and tracked using standard medical imaging or blood tests, as defined by recognised guidelines
  • People with a related condition called Small Lymphocytic Lymphoma (SLL), alone or alongside CLL, may also be eligible

Who may not be able to join:

  • People who have received anti-cancer treatment (such as chemotherapy, biological therapy, or immune-modifying drugs) within approximately the past 28 days or longer before starting the trial (low-dose prednisone at up to 10 mg/day is an exception)
  • People who still have significant side effects from previous cancer treatment (other than hair loss or nail changes) that have not largely resolved
  • People who have had full-course radiotherapy within the past 21 days before starting the trial (limited palliative radiation to a small area is an exception)
  • People who have taken part in another clinical trial involving an experimental treatment within the past 28 days or longer
  • People diagnosed with specific types of lymphoma including Burkitt's lymphoma, Burkitt-like lymphoma, post-transplant lymphoma, primary mediastinal large B-cell lymphoma, cutaneous lymphomas, mycosis fungoides, or Sézary syndrome
  • People with lymphoma that has spread to the brain or spinal cord and is either untreated, causing symptoms, or was treated less than 6 months ago (those treated more than 6 months ago with no current symptoms may be eligible — confirm with trial site)
  • People whose lymphoma requires urgent, immediate treatment to reduce tumour size
  • People with a slow-growing (indolent) lymphoma that does not yet meet the accepted medical criteria for needing treatment
  • People taking certain medications that affect how the body processes drugs (inhibitors of P-gp, BCRP, or UGT1A1) that cannot be stopped at least one week before starting the trial
  • People who have had major surgery (requiring general anaesthesia) within the past 28 days
  • People with an active infection currently requiring treatment with medicines (preventive antibiotic use is an exception)
  • People known to be living with HIV or to have an AIDS-related illness
  • People with active or ongoing hepatitis B or hepatitis C infection
  • People who are expected to need another type of cancer treatment during the trial period
  • People with certain serious or uncontrolled heart conditions, including heart failure, angina, a recent heart attack, stroke, bypass surgery, a mini-stroke, or a blood clot in the lungs within the past 3 months
  • People with heart rhythm problems currently requiring treatment, or who were treated for heart rhythm problems in the past 3 months
  • People with an abnormal heart electrical reading (a specific measurement called QTcF greater than 470 ms) at screening
  • People with other serious uncontrolled medical conditions — such as uncontrolled high blood pressure, active stomach ulcers, significant bleeding problems, or serious kidney, liver, lung, hormonal, or psychiatric conditions — that in the trial doctor's opinion could affect safety or results
  • People who currently have, or are suspected of having, a COVID-19 infection at the time of screening or at the start of the trial
  • People who have had another separate cancer diagnosis within the past 5 years (exceptions include certain treated skin cancers and cervical cancer in situ)
  • Women who have a positive pregnancy test at screening or enrolment
  • Women who are breastfeeding
  • Women who could become pregnant, or men whose partners could become pregnant, who are not willing to use reliable contraception during the trial and for at least 28 days after the last dose of the trial treatment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Akhil Kumar, Aurigene Oncology Limited

Phone: +91- 8104730078

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Aurigene Discovery Technologies Limited
Registry
ClinicalTrials.gov
Start date
15 January 2025
Est. completion
15 January 2027

Where this trial is recruiting

🇮🇳 India

Primary endpoints

First cycle Dose Limiting Toxicities (DLT).; Safety of AUR112 as measured by the number of participants with treatment related adverse events (AE) graded according to NCI CTCAE version 5.0; To determine the doses to be recommended for evaluation in future studies.; Pharmacokinetics: Maximum concentration (Cmax); Pharmacokinetics: Time to Maximum concentration (Tmax); Pharmacokinetics: Area under the curve (AUC); Pharmacokinetics: Mean Residence Time (MRT); Pharmacokinetics: Terminal elimination half-life; Maximum concentration (Cmax) administered under fasting/fed condition; Time to Maximum co...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov